Le autorità regolatorie europee e statunitensi hanno concesso un percorso accelerato per l’approvazione dell’anti-CCR5 maraviroc della Pfizer. Il dossier è stato sottoposto a dicembre 2006 ad entrambe le autorità . E’ il primo di una nuova classe di farmaci in sperimentazione.
Siamo tutti pronti a vedere presto i nuovi studi riguardo a questa molecola della Pfizer, che segnerà l’entrata in campo di una nuova classe terapeutica per il trattamento dell’HIV. L’azione sarà extra-cellulare e non propriamente “antivirale” come fino ad ora era accaduto.
Le autorità regolatorie europee e statunitensi hanno concesso un percorso accelerato per l’approvazione della molecola. Il primo incontro negli USA (FDA) che sarà cruciale per l’approvazione è fissato per il 24 Aprile. Molto brevi dunque i tempi.
Il comitato indipendente di controllo (DSMB) ha dato a metà gennaio 2007 parere favorevole al proseguimento del programma clinico sia su pazienti naive che su pazienti pre-trattati.
Fonte: Pfizer.com
Canale informativo: Nadir Notizie
FDA and EMEA Will Review Pfizer’s Maraviroc for Accelerated Approval in U.S. and Europe
By Ronald Baker, PhD
The U.S. Food and Drug Administration (FDA) and the European Agency for the Evaluation of Medicinal Products (EMEA) will soon review applications for accelerated approval of the novel anti-HIV drug maraviroc, according to an announcement this week by Pfizer.
FDA and EMEA grant accelerated approval reviews to experimental therapies that have demonstrated potentially significant improvements over medications currently on the market.
If approved by the European and American regulatory agencies as expected, maraviroc will become the first member of the CCR5 antagonist drug class to win approval. The CCR5 antagonists have a unique mechanism of action against HIV that works by blocking entry of the virus into as yet uninfected cells. All currently available anti-HIV drugs (except for T-20 or Fuzeon) interfere with the replication of HIV inside cells that are already infected with the virus.
“There is a profound global need for new medicines to help HIV/AIDS patients,” said John LaMattina, President of 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. FDA Antiviral Drugs Advisory Committee will conduct its priority review of maraviroc at an open public hearing 8 AM to 4 PM on Tuesday, April 24, 2007. The review will take place at the FDA, Center for Drug Evaluation and Research Advisory Committee Conference Room, Rooom 1066, 5630 Fishers Lane, Rockville, MD.
Maraviroc Development Background
The discovery of maraviroc dates back to 1997, when Pfizer research scientists in Sandwich, UK, designed the molecule following the publication of 2 significant research findings.
A study published in 1996 described resistance to HIV-1 infection in certain Caucasian subjects, and the same year, another journal reported the binding of HIV to the CCR5 receptor. Scientists noted that about 1% percent of Europeans who lacked 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.
“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,” said Dr. Ethan Weiner, Senior Vice President, Pfizer Global Research and Development.
Pivotal Trials
The marketing applications for maraviroc follow Pfizer’s review of efficacy and safety data from 2 pivotal Phase III trials. The trials, MOTIVATE-1 and MOTIVATE-2 (Maraviroc plus Optimized Therapy In Viremic Antiretroviral Treatment-Experienced patients), provided 24-week data comparing optimized background therapy, with or without maraviroc, in over 1000 highly treatment-experienced patients with CCR5-tropic HIV-1.
These study results have been accepted for presentation at an important upcoming scientific conference in the U.S.
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 III registration trials, in both treatment-naive and treatment-experienced patients should continue as currently designed.
Update on Maraviroc 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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