terça-feira, fevereiro 15, 2005
Inibidor de maturação em desenvolvimento acelerado
Hiv and Hepatitis 14.02.05
FDA Grants Fast-Track Review Status to PA-457, First in a New Class of Anti-HIV Drugs
Panacos Pharmaceuticals Inc. said that US regulators will review its experimental drug PA-457 to combat HIV on an accelerated basis. Currently in Phase II clinical testing, the drug is designed to treat HIV positive individuals who have become resistant to available treatments as well as those who have wild-type HIV.
It is the first in a new class of drugs termed maturation inhibitors. “It targets a novel point in virus replication, making it effective against viruses that are currently resistant to other treatments,” Dr. Carl Wild, Panacos’ Chief Science Officer, told Reuters last July in Bangkok at the World AIDS conference.
Specifically, PA-457 blocks the processing of a viral capsid protein. The US Food and Drug Administration (FDA) has granted the drug “fast-track” status, which allows the agency to accept portions of a marketing application for review before the full package is complete. A few experimental drugs that appear to meet an “unmet need” may gain FDA “fast-track” status. This designation for a new drug usually results in faster FDA approval and broader access to an experimental drug than approval through the standard FDA review process.
PA-457 is a once-daily oral drug, which makes it an attractive candidate for approval. It significantly reduced the plasma viral load in patients in early clinical trials. More complete results of those trials will be presented this month at the 12th CROI meeting in Boston (February 22-25, 2005) . In the second half of this year the company plans to initiate Phase IIb studies of the drug, designed to pave the way for a pivotal Phase III trial 2006.