Pfizer's Selzentry Treatment for HIV Approved By FDA
Posted on: Tuesday, 7 August 2007, 15:10 CDT
Pfizer has reported that the FDA has approved its Selzentry treatment for HIV, the first in a new class of oral HIV medicines in 10 years.
Selzentry (maraviroc) 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 expected to be available in the US 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 US.
Source: Datamonitor
Related Articles
- CSL Behring Receives Orphan-Drug Exclusivity for RiaSTAP(TM), First and Only Approved Treatment of Acute Bleeding Episodes in Patients with Congenital Fibrinogen Deficiency
- Positive Data From Lung Study May Lead to First FDA Approved Treatment for Pulmonary Fibrosis
- New Roche Dual Target HIV-1 Test Approved for Use in European Union
- Pfizer Gets FDA Approvable Letter for Dalbavancin
- National Surveys Reveal Differing Perceptions Among HIV-Positive Patients and Physicians About HIV and Its Treatment
- Botswana Children With HIV/AIDS Miss Treatment
- Pfizer Receives FDA Approval for Eraxis(TM) to Treat Candidemia, a Potentially Life-Threatening Bloodstream Infection
- Paying for HIV Drugs Endangers Treatment: MSF
- MGI PHARMA And SuperGen Provide Regulatory Status Updates For Dacogen(TM) (Decitabine) Injection For MDS; Approvable Letter Response Submitted to FDA; Confirms Phase 3 Results; European Regulatory Strategy Revised
- IL-7 is a Potent and Proviral Strain-Specific Inducer of Latent HIV- 1 Cellular Reservoirs of Infected Individuals on Virally Suppressive HAART
 |
 |
User Comments (0)
RSS Feeds