Under PEPFAR, Matrix Labs gets OK to sell zidovudine tablets
PITTSBURGH — A subsidiary of Mylan has won approval to sell a generic drug for HIV and AIDS in developing countries under the President’s Emergency Plan for AIDS Relief.
Mylan announced Thursday that Matrix Labs won Food and Drug Administration approval for zidovudine tablets in the 100-mg strength. The drug is a generic version of ViiV Healthcare’s Retrovir, an antiretroviral sold as a water-dispersible tablet. The drug is designed to treat HIV and AIDS in children and prevent transmission of the virus from pregnant mothers to their children.
“According to PEPFAR, prevention of mother-to-child transmission of HIV is extraordinarily effective,” Mylan president Heather Bresch stated. “Without PMTCT, 25% to 40% of babies of HIV-positive mothers will be born infected; with PMTCT, that number drops to below 5%.”
Benlysta approved as lupus treatment
SILVER SPRING, Md. — The Food and Drug Administration has approved a treatment for lupus made by GlaxoSmithKline and Human Genome Sciences, the agency said Wednesday.
The FDA approved Benlysta (belimumab), a treatment for systemic lupus erythematosus, the first new treatment for the autoimmune disease in 56 years.
“Benlysta, when used with existing therapies, may be an important new treatment approach for healthcare professionals and patients looking to help manage symptoms associated with this disease,” FDA Office of Drug Evaluation II director Curtis Rosebraugh said.
Prior to Benlysta’s approval, the only drug approved specifically for treating the disease was Sanofi-Aventis’ Plaquenil (hydroxychloroquine) and corticosteroids. Aspirin was approved to treat the disease in 1948.
The approval likely will be a welcome relief for many patients with the disease, a potentially fatal condition in which the body attacks healthy tissues, affecting the joints, skin, kidneys, lungs, heart and brain. Lupus affects between 300,000 and 1.5 million people in the United States.
Lilly names new VP oncology research
INDIANAPOLIS — Eli Lilly on Thursday announced that it has named Greg Plowman VP oncology research and SVP for ImClone Systems research.
Plowman will oversee the oncology research efforts of both Lilly and ImClone, the drug maker’s subsidiary that it acquired in 2008. He will report to Jan Lundberg, EVP science and technology and Lilly Research Labs president, as well as Bernhard Ehmer, ImClone president.
Prior to accepting the position at Lilly, Plowman served as senior director of research for Genentech for six years. He officially will join the company March 28.