Bristol-Myers Squibb submits Atripla to EU regulators

Bristol-Myers Squibb (BMS) and its development partners, Gilead Sciences and Merck Sharp & Dohme, have submitted Atripla, a new triple-combination therapy for the treatment of HIV, to European regulators for marketing approval.

The Committee for Medicinal Products for Human Use will first provide an opinion to the European Medicines Agency before the application is validated for the drug, intended to be used as a stand-alone therapy or in combination with other antiretroviral drugs.

Atripla has already been approved in the US and comprises efavirenz, marketed by Bristol-Myers Squibb as Sustiva, as well as two Gilead drugs – Emtriva and Viread.

Lamberto Andreotti, president of worldwide pharmaceuticals at Bristol-Myers Squibb, said the company is committed to developing new HIV therapies and is pleased to be working with Gilead and MSD.

“With the filing of Atripla in Europe, we are one step closer to making available another effective treatment option for European adult patients living with HIV/Aids,” he said.

The treatment may have the ability to simplify treatment for many HIV-infected patients, concluded Kevin Young, executive vice president of commercial operations at Gilead.

Last month, Bristol-Myers Squibb in-licensed the rights to MIV-170, a new HIV therapy developed by Medivir, in exchange for $7.5 million (four million pounds). The drug could provide a new treatment as part of a new structural class of non-nucleoside reverse transcriptase inhibitors.