O blog do GAT

AidsPortugal 30.07.07

O Maraviroc, o primeiro de uma nova classe de fármaco contra o VIH chamada antagonistas das citoquinas, ou inibidores do CCR5, recebeu ontem aprovação científica do corpo regulador de fármacos da União Europeia, a EMEA, e poderá estar disponível para prescrição em Novembro.

O Maraviroc, cujo nome comercial será Celsentri, será prescrito para doentes já tratados que apenas têm vírus com tropismo para o CCR5 (VIH que usa o receptor CCR5 para entrar nas células CD4).

Os inibidores do CCR5 bloqueiam o receptor CCR5, tornando impossível a ligação do VIH a este alvo. Bloquear o receptor implica que o VIH seja capaz de infectar menos células alvo.
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Etiquetas: maraviroc, Pfizer

For immediate release: Contact: Shreya Prudlo
August 6, 2007 (212) 733-4889

PFIZER’S SELZENTRY^TM (MARAVIROC) TABLETS, NOVEL TREATMENT FOR HIV, APPROVED BY FDA

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First in a New Class of Oral HIV Medicines in More Than a Decade

NEW YORK, August 6 – Pfizer Inc announced today that the U.S. Food and Drug Administration (FDA) has approved Selzentry^TM (maraviroc) tablets, the first in a new class of oral HIV medicines in more than 10 years. Selzentry blocks viral entry into white blood cells, significantly reducing viral load and increasing T-cell counts in treatment-experienced patients infected with a specific type of HIV.

“There is a profound need for new medicines to treat HIV. In the United States, thousands of patients living with HIV are running out of effective medications that can control their virus,” said Dr. Joseph Feczko, Pfizer’s chief medical officer. “The approval of Selzentry for treatment-experienced patients is a significant breakthrough, and we continue its development in a spectrum of other patients living with HIV/AIDS.”

The FDA granted accelerated approval to Selzentry for combination antiretroviral treatment of adults infected with only CCR5-tropic HIV-1 detectable, who have evidence of viral replication and have HIV-1 strains resistant to multiple antiretroviral agents. A diagnostic test confirms whether a patient is infected with CCR5-tropic HIV-1, which is also known as “R5 virus.”

An accelerated approval allows for earlier approval of drugs that provide a meaningful therapeutic advantage over existing treatment for serious or life-threatening diseases. This approval is based on 24-week data. Longer-term data will be required before the FDA can consider traditional approval for Selzentry.

Selzentry is the first in a class of drugs known as CCR5 antagonists, which block the CCR5 co-receptor, the virus’ predominant entry route into T-cells. Selzentry stops the R5 virus on the outside surface of the cells before it enters, rather than fighting the virus inside as do all other classes of oral HIV medicines.

Selzentry is expected to be available in the U.S. by the middle of September.

Pfizer is currently submitting marketing applications around the world and recently received a positive opinion from the CHMP in the EU. Pfizer intends to commercialize the product with the name Celsentri outside of the U.S.

Pfizer has established a multi-national expanded access program (EAP), a clinical study that provides Selzentry in countries where it is not yet commercially available to patients who have limited treatment options due to resistance or intolerance to existing therapies.

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Data Supporting Selzentry Approval

The FDA approval of Selzentry is based on 24-week data from the ongoing double-blind, controlled MOTIVATE clinical trials. In the MOTIVATE trials, approximately twice as many patients receiving Selzentry combined with an optimized background therapy (OBT) achieved undetectable viral load at 24 weeks compared with those receiving OBT alone.

In the trials, patients receiving Selzentry with OBT also experienced significantly greater viral load reductions and increases in CD4 cell counts compared with those receiving OBT alone.

Patients in the MOTIVATE trials were highly treatment-experienced, with 69.7% receiving Selzentry and OBT and 66% receiving OBT alone having two or fewer active drugs in their optimized background regimen.

Patients receiving Selzentry in the studies had a rate of discontinuation due to adverse events (3.8%) which was similar to the group receiving OBT plus placebo (3.8%). The most common adverse reactions (>8% incidence and greater than placebo) are cough, pyrexia (fever), upper respiratory tract infections, rash, musculoskeletal symptoms, abdominal pain, and dizziness.

Important Safety Information

Selzentry does not cure HIV infection or AIDS, and does not prevent passing HIV to others.

Although there was no overall increase in serious liver function test abnormalities in patients treated with Selzentry, hepatotoxicity has been reported with Selzentry use. Evidence of a systemic allergic reaction (e.g., pruritic rash, eosinophilia or elevated IgE) prior to the development of hepatotoxicity may occur. Patients with signs or symptoms of hepatitis or allergic reaction following use of Selzentry should be evaluated immediately.

The safety and efficacy of Selzentry have not been specifically studied in patients with significant underlying liver disorders. However, caution should be used when administering Selzentry to patients with pre-existing liver dysfunction or who are co-infected with viral hepatitis B or C.

In clinical studies, more cardiovascular events, including myocardial ischemia and/or infarction, were observed in patients who received Selzentry as compared to placebo. Selzentry should be used with caution in patients at increased risk for cardiovascular events.

Caution should be used when administering Selzentry in patients with a history of postural hypotension or who receive concomitant medication known to lower blood pressure. Patients should be advised that if they experience dizziness while receiving Selzentry, they should avoid driving or operating machinery.

Etiquetas: maraviroc, Pfizer

Dum activista americano:

You may have noticed that this was the shortest press release you’ve ever seen for what looked like the approval of a new drug. This may be the first time some have heard this word “approvable” used. It’s not a mistake or typo. It is different than “approved.” Maraviroc has been declared “approvable” but it is not yet “approved.” This means that the FDA has agreed that the drug has been shown to be safe and effective, but that there are still other issues that need to be worked out with the company before they are permitted to sell the drug. The FDA was required by law to “respond” by today to Pfizer’s application. This is their response.

The main issue still under debate is the label indication. This includes the question of the type of patient the drug is being approved for, and maybe include the question of whether or not the Trophile diagnostic assay will be recommended or required before prescribing the drug. There may also be other issues as well.

It is not unusual for the FDA to issue an “approvable” letter instead of a formal approval, but it has never before happened with an HIV drug. In general, the FDA has gone right to “approved” for drugs that treat people with life threatening illnesses. In this case, I think they had hoped to finish the discussion about the label by today but they weren’t able to do so. So the real “approval” still awaits us. When the FDA issues an “approvable” letter in other, not so serious diseases, it is sometimes followed by announcement of requirements for additional studies. That is very unlikely to be the case here. The unfinished business, from the FDA’s point of view, is about the label indication.

This also affects the announcement of the price. The final price won’t be set until the label indication is firmed up, as this will affect likely sales of the drug. I don’t know if the approval will come in a few days or a few weeks, though I’m inclined to think it’s only a few days off. But there is no question that the drug will be approved. Just not today...

For immediate release

June 20, 2007

PFIZER RECEIVES APPROVABLE LETTER FROM FDA FOR MARAVIROC

NEW YORK, June 20 – Pfizer announced today the U.S. Food and Drug Administration (FDA) issued an approvable letter for maraviroc, which is under review as a therapy for treatment-experienced patients infected with CCR5-tropic HIV-1.

We continue our discussions with the FDA to address outstanding questions and finalize the product labeling as soon as possible. Pfizer is committed to making maraviroc available to the thousands of patients with HIV whose virus has become resistant to one or more currently available treatment options.

To date, more than 2,000 patients worldwide have received or are currently receiving treatment with maraviroc through clinical trials. Pfizer has also established an expanded access program (EAP) in 30 countries. The EAP is a clinical study that provides maraviroc in countries to patients who have limited treatment options prior to approval.

Pfizer is currently in the process of submitting marketing applications around the world to make maraviroc available globally.

Etiquetas: maraviroc, Pfizer

24.04.07

The FDA Antiviral Drug Advisory Committee voted unanimously to recommend accelerated approval of Maraviroc, the first CCR5 inhibitor HIV drug, by the FDA. We probably will hear from the FDA within a few months. The FDA usually follow advise by this panel so we can expect FDA approval.

Ongoing now is discussion of post-approval studies.

Painel da FDA Apoia Fármaco Para o VIH

Etiquetas: FDA, maraviroc

Pharmalot 12.04.07

April 12, 2007
AIDS Market To Mushroom

The launch of new drugs and an increase in the number of people
diagnosed with HIV is set to make AIDS medicine a $10.6 billion market
by 2015, according to a Datamonitor report. That would be a significant
increase from about $7.1 billion in 2005.

For drugmakers, this brings good and bad news. Big pharma may be under
pressure to cut prices in the developing world, but selling HIV drugs in
the West remains a lucrative and fast-growing business. The research
firm says sales growth will come from new drugs with novel mechanisms
and next-generation versions of existing meds.
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Reuters 12.04.07:
Sales, as a result, should rise significantly from about $7.1 billion in
2005, benefiting a clutch of companies with promising new products,
including Merck & Co Inc. (NYSE:MRK), Pfizer Inc. (NYSE:PFE, Gilead
Sciences Inc. (NasdaqGS:GILD) and Johnson & Johnson (NYSE:JNJ).
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But at the same time the disease is also increasing in the developed
world, with an estimated 2.1 million people in North America and Western
Europe living with HIV in 2006, up from 1.9 million in 2004.

"Advances in antiretroviral therapy have turned HIV from a universally
feared death sentence into a chronic disease with an average life
expectancy similar to that of Type 2 diabetes," Datamonitor analyst
Mansi Shah said.

"Because of this, attitudes towards HIV have become relatively blase
amongst some groups."

Notable new types of drugs include Pfizer's maraviroc, a CCR5 inhibitor,
and Merck's raltegravir, an integrase inhibitor, which are expected to
be launched in 2007 and 2008 respectively.

They will complement new generation forms of existing drug classes, such
as Johnson & Johnson's recently approved Prezista, a protease inhibitor.

Such products offer new treatment options for the growing number of
patients whose disease no longer responds to existing drugs.

At the same time, other companies are developing improved fixed-dose
drug combinations, including Atripla from Gilead, which combines the
components of current drug cocktails into a single pill that can be
taken once a day.

Atripla was launched in the United States last year and is expected to
take market share from its two components Truvada and Sustiva, as well
as competitor drugs such as GlaxoSmithKline Plc's (LSE:GSK.L) Combivir,
Datamonitor said.

The global market for all pharmaceuticals grew 7 percent last year to
$643 billion, according to estimates from another market research
company, IMS Health, released last month.

Etiquetas: ARVs, atripla, custos, darunavir, maraviroc, raltegravir

For immediate release:
February 13, 2007

PFIZER’S MARAVIROC TO RECEIVE ACCELERATED REGULATORY REVIEWS IN THE U.S. AND EUROPE
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If Approved, Maraviroc will be the First in a New Class of Medications Available for HIV Treatment

NEW YORK, February 13 – Pfizer announced today that marketing authorization applications for maraviroc will receive accelerated review in both the United States and Europe. Accelerated reviews are granted to potential medicines that, if approved, would represent significant improvements over current therapies.

If approved by the regulatory agencies, maraviroc will be the first in a new class of HIV/AIDS treatments called CCR5 antagonists that work by blocking viral entry. Rather than fighting HIV inside white blood cells, CCR5 antagonists prevent the virus produced by infected cells from entering uninfected cells by blocking its predominant entry route, the CCR5 coreceptor.

“There is a profound global need for new medicines to help HIV/AIDS patients,” said John LaMattina, president, Pfizer Global Research and Development. “We expect that CCR5 antagonists, like maraviroc, will become critically important new treatment options for patients who are resistant or intolerant to their current HIV/AIDS therapies.”

The U.S. Food and Drug Administration (FDA) priority review process takes place within a six-month period. Pfizer submitted the U.S. and EU maraviroc marketing applications in December 2006. An FDA Advisory Panel is scheduled for April 24. Pfizer has begun pursuing regulatory approval for maraviroc in other
countries to enable broad access to the drug.

Moving with Urgency
The discovery of maraviroc dates back to 1997 when Pfizer research scientists in Sandwich, UK designed the molecule following the publication of two significant research findings. A study was published in 1996 that described resistance to HIV-1 infection in certain Caucasian subjects, and in the same year, another journal reported the binding of HIV to the CCR5 receptor. Scientists noted that about one percent of Europeans who lacked the genes for CCR5 receptors were the very ones who were resistant to acquiring HIV infection. This finding suggested that blocking the virus’s entry through this gateway may lead to
a breakthrough therapy. Based on these emerging scientific insights and patient need, the maraviroc team significantly accelerated development time.

“This is the kind of targeted science that underscores our commitment to research and development in a range of infectious diseases where there is high human cost due to drug resistance,” said Dr. Ethan Weiner, senior vice president, Pfizer Global Research and Development. “Maraviroc is an outstanding example of rapid development and continuous innovation through which Pfizer researchers quickly translated a scientific hypothesis into a promising compound in this area of great medical need.”

Maraviroc is the seventh Pfizer new drug application to receive “Priority Review” status from the FDA over the past two years. Other priority review FDA approvals include Sutent for advanced kidney cancer and gastrointestinal stromal tumors, Chantix for smoking cessation, Revatio for pulmonary arterial hypertension, and Macugen for age-related macular degeneration which can lead to blindness in elderly patients.

Pivotal Trials
The marketing applications follow Pfizer’s review of efficacy and safety data from two pivotal phase 3 trials. The trials, MOTIVATE-1 and 2 (Maraviroc plus Optimized Therapy In Viremic Antiretroviral Treatment-Experienced patients), represent 24-week data comparing Optimized Background Therapy, with or without
maraviroc, in over 1,000 highly treatment-experienced patients with CCR5-tropic HIV-1. These study results have been accepted for presentation at an upcoming HIV conference.

In addition, the independent Data Safety Monitoring Board (DSMB)for maraviroc met on January 15, 2007 and continues to monitor the ongoing clinical program. The DSMB recommended that the maraviroc Phase 3 registrational trials, in both treatment-naïve and treatment-experienced patients, continue as currently
designed.

Update on Expanded Access Program
In December 2006, Pfizer announced plans to establish a multinational Expanded Access Program to provide maraviroc to patients with limited available treatment options based on its safety and efficacy observed in clinical trials to date. The program is now open for enrollment with a target to enroll patients from over 30 countries.
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Etiquetas: ARVs, EMEA, maraviroc, Pfizer