Pfizer treatment approved for patients

Pfizer’s HIV/Aids treatment Selzentry has been approved for treatment-treatment experienced adults with CCR5-tropic HIV-1 by the US Food and Drug Administation (FDA).

When in combination with other antiretrovirals, the drug is now the latest fully approved treatment for the virus.

It was originally granted accelerated conditional approval in August last year, following 24-week data from pivotal phase three studies.

David Hardy, managing director and chief of the division of infectious diseases at the Cedars-Sinai Medical Centre, said: “Selzentry, the first oral entry inhibitor, has proven to be an effective and well-tolerated treatment option for treatment-experienced patients whose HIV has become resistant to other treatments, but remains susceptible to this new class of medications.”

The latest approval follows 48-week data from the Motivate (Maraviroc Plus Optimised Therapy in Viremic Antiretroviral Treatment Experienced Patents) studies, which compared the effectiveness and safety of the drug.

Full endorsement by the FDA is given after it is satisfied with longer-term data and, once granted, restrictions on promotion and/or distribution are removed.

In other news, the company – along with Wyeth – has been sued by Nevada’s attorney general for alleged deceptive trade practices.

The accusations relate to the companies’ selling of four hormone therapy drugs, Premarin, Prempro, Premphase and Provera.