Anche la Food and Drug Administration approva il primo medicinale per il trattamento dell’HIV-1 di una nuova classe: gli antagonisti del co-recettore CCR5, che agiscono selettivamente sul virus R5 tropico al di fuori della cellula CD4, impedendone l’ingresso. In USA si chiamerà Selzentry, mentre in Europa Celsentri.
COMUNICATO STAMPA PFIZER:
PFIZER’S SELZENTRYTM (MARAVIROC) TABLETS, NOVEL TREATMENT FOR HIV,
APPROVED BY FDA
NEW YORK, August 6 – Pfizer Inc announced today that the U.S. Food and Drug Administration (FDA) has approved Selzentry (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.
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.
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
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 coinfected 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.
Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy. Selzentry antagonizes the CCR5 co-receptor located on some immune cells, and therefore could potentially increase the risk of developing infections and malignancy.