sexta-feira, outubro 12, 2007
FDA aprova raltegravir
When used with other anti-HIV medicines, raltegravir may reduce the amount of HIV in the blood and may increase white blood cells, called CD4+ (T) cells, that help fight other infections.
Raltegravir received a priority review by the FDA. The review and approval of the New Drug Application was completed in within six months.
FDA’s approval of raltegravir is based on efficacy and safety data from two double-blind, placebo-controlled studies (BENCHMRK 1 and BENCHMRK 2) in 699 highly antiretroviral treatment-experienced HIV-1 infected adult patients (16 years or older, with documented resistance to at least 1 drug in each of 3 Classes (NNRTIs, NRTIs, PIs) of antiretroviral therapies). 462 patients used the recommended 400 mg dose twice daily in combination with other currently available HIV medications; 237 patients received a placebo in combination with other currently available HIV medications. The mean changes in plasma HIV-1 RNA from baseline were -1.85 log10 copies/mL in the ISENTRESS 400 mg twice daily arm and -0.84 log10 copies/mL for the control arm. The mean increase from baseline in CD4+ cell counts was higher in the arm receiving ISENTRESS 400 mg twice daily (89 cells/mm3) than in the control arm (35 cells/mm3).
The most common adverse events reported with raltegravir were diarrhea, nausea, and headache. Blood tests showed abnormal elevated levels of a muscle enzyme in some patients receiving raltegravir. Caution is advised when using raltegravir in patients at increased risk for certain types of muscle problems, such as patients taking other medications that can cause muscle problems.
Raltegravir has not been studied in pregnant women. Women who are taking HIV medications when they get pregnant are advised to ask their physician about registering with the Antiretroviral Pregnancy Registry.
As with other treatments for HIV, patients taking raltegravir may still develop infections, including opportunistic infections or other conditions that may develop in patients living with HIV-1 infection, and can still pass the virus on to others through sexual contact, sharing needles, or being exposed to blood.
The long-term effects of raltegravir are not known at this time, and its safety and effectiveness in children less than 16 years of age has not been studied.
Raltegravir is distributed by New Jersey-based Merck & Co., Inc.
Etiquetas: FDA, raltegravir
quarta-feira, junho 27, 2007
Raltegravir na FDA
FDA Priority Review Granted for ISENTRESS™ (raltegravir), Merck's
Investigational Integrase Inhibitor for HIV
Investigational Integrase Inhibitor a New Class of Oral HIV Medication
WHITEHOUSE STATION, N.J., June 27, 2007 -- Merck & Co., Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for ISENTRESS™ (raltegravir, previously known as MK-0518). Data in the NDA support the proposed use of ISENTRESS in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-experienced patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy (ART).
The FDA granted ISENTRESS priority review status, a designation for investigational products that address unmet medical needs. Under the priority review designation, the FDA is expected to review and act on the NDA for ISENTRESS within six months of submission. Merck anticipates FDA action by mid-October and as planned is also moving forward with regulatory filings in countries outside of the United States.
If approved, ISENTRESS would be the first in a new class of antiretroviral agents called integrase inhibitors that inhibit the insertion of HIV DNA into human DNA. Inhibiting integrase from performing this essential function blocks the ability of the virus to replicate and infect new cells. There are drugs in use that inhibit two other enzymes critical to the HIV replication process – protease and reverse transcriptase – but currently no approved drugs inhibit integrase.
(...)
Etiquetas: Merck, raltegravir
segunda-feira, maio 28, 2007
Status do acesso precoce ao MK-0518 em Portugal
25.05.07 - Informação da Merck:
O programa do acesso precoce ao MK-0518 (raltegravir) em Portugal já foi iniciado. Caso algum doente pense ter a necessidade de utilizar este medicamento deve de discutir este tema com o seu médico assistente para que este o posso aconselhar da melhor forma.
Caso o médico assistente deseje iniciar o tratamento com este medicamento com provas preliminares de benefício clínico, poderá solicitar informação à Merck Sharp & Dohme Portugal e ser-lhe-à facultada toda a documentação necessária para que possa solicitar à agência regulamentar a autorização de utilização especial do MK-0518. A decisão da necessidade de tratar o doente com este medicamento baseando-se nas provas preliminares de benefício clínico é da exclusiva responsabilidade do médico que o assiste.
Em Portugal o programa de autorização especial do MK-0518 não está limitado a nenhum hospital. Qualquer doente que de acordo com o médico assistente cumpra as condições para participar neste programa poderá ter acesso precoce ao medicamento.
www.msd.pt
Merck Sharp & Dohme
Quinta da Fonte - Edif. Vasco da Gama, Nº 19
P.O. Box 214 - 2770-192 Paço D' Arcos - PORTUGAL
Phone: +351 21 446 58 02 Fax: +351 21 446 57 99
The criteria for getting raltegravir through the EAP are:
1. Limited or no treatment options due to resistance or intolerance
> Resistance to 1 in each of 3 classes of drugs
> Clinically significant side effects that contraindicated use of any drug in that category
2. Not achieving adequate viral suppression on current regimen and at increased risk of clinical or immunological progression.
3. Clinically stable and on the same antiretrovirals for at least 2 weeks.
Etiquetas: EAP, Merck, raltegravir
domingo, abril 22, 2007
Mercado da sida não pára de crescer
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.
(...)
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).
(...)
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
sábado, abril 21, 2007
Notícias do programa de acesso alargado ao raltegravir
Há já quem diga que a Merck não deve estar muito interessada em dar este aparentemente bom medicamento de borla. O futuro mercado já está assegurado.
Etiquetas: EAP, raltegravir
