FDA grants priority review to Gilead’s Truvada for HIV prevention
FOSTER CITY, Calif. — The Food and Drug Administration is giving priority review to a drug made by Gilead Sciences that the company is investigating for the prevention of HIV.
Gilead said the FDA gave the special designation to its application for Truvada (emtricitabine and tenofovir disoproxil fumarate) for pre-exposure prophylaxis, or PrEP, to reduce the risk of HIV infection. The FDA originally approved Truvada for treating HIV infection in 2004, and it is currently the most prescribed antiretroviral drug in the United States.
Gilead said that if approved, Truvada would be the first drug indicated for reducing the risk of acquiring HIV. The company’s regulatory filing, which it submitted on Dec. 15, is based on results of a study sponsored by the National Institutes of Health and the University of Washington that supported the use of Truvada in reducing the risk of HIV infection.
Bristol-Myers Squibb completes Inhibitex acquisition
NEW YORK — Bristol-Myers Squibb has completed its acquisition of a developer of hepatitis C treatments.
Bristol said it successfully completed its tender offer for all of the outstanding shares of common stock of Alpharetta, Ga.-based Inhibitex, at a purchase price of $26 per share via a “short form merger” in which all such shares were converted into the right to receive the aforementioned share price in cash and without interest, less any applicable withholding taxes.
Bristol said it intends to delist and de-register Inhibitex common stock as promptly as practicable following the effective time of the merger.
Bydureon officially hits market
SAN DIEGO — Amylin Pharmaceuticals and Alkermes announced that their Type 2 diabetes treatment now is available by prescription in U.S. pharmacies.
Bydureon (exenatide extended-release for injectable suspension) received approval from the Food and Drug Administration on Jan. 27 as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes.
In line with the official launch, the drug makers said eligible patients will have access to the Bydureon Steady Savings Card to help offset co-pay costs by saving up to $50 per month for up to 24 months. Details about the program can be found here.