Mylan subsidiary receives tentative FDA approval for AIDS medication
PITTSBURGH The Food and Drug Administration has given the first tentative approval under the President’s Emergency Plan for AIDS Relief to a Mylan subsidiary.
Mylan announced Monday that Matrix Labs, in which the Pittsburgh-based company owns a 71.2% controlling interest with plans to acquire the rest, received the tentative approval for emtricitabine and tenofovir disoproxil fumarate tablets in the 200-mg/300-mg strength.
The tablets are a generic version of Gilead Sciences’ Truvada, which has annual sales of more than $2 billion, according to Gilead financial data.
“This product approval is yet another important step in providing access to a range of critical HIV medications to patients in developing countries,” Mylan vice chairman and CEO Robert Coury stated. “Mylan and Matrix continue to make a significant contribution to bringing down the cost of these vital treatments through the expansion of our high-quality anti-retroviral franchise.”
FDA approves fast-track designation for Hodgkin lymphoma treatment
BOTHELL, Wash. An investigational drug for treating Hodgkin lymphoma has received fast-track designation from the Food and Drug Administration, the maker of the drug has announced.
Seattle Genetics, based in the Seattle suburb of Bothell, Wash., said it received the designation for SGN-35, for which it hopes to soon start a phase 2 study.
“Receiving fast-track designation is another important component of our regulatory strategy for SGN-35 and a key step for this program,” Seattle Genetics president and CEO Clay Siegall said. “With our pivotal trial underway, we expect data in 2011.”
That year, Siegall said, the company hopes to file for regulatory approval, possibly launching the drug in 2012. So far, the drug has received orphan drug designation in the United States and Europe for Hodgkin lymphoma and anaplastic large cell lymphoma.
GSK submits study results for HPV, cervical cancer vaccination
PHILADELPHIA British drug maker GlaxoSmithKline has submitted data from a phase 3 efficacy study on a vaccine for human papillomavirus and cervical cancer to the Food and Drug Administration, the company announced Monday.
The drug, Cervarix (human papillomavirus vaccine [Types 16, 18] recombinant, adjuvanted, adsorbed), is designed to prevent HPV types 16 and 18. The study, called HPV-008, enrolled more than 18,600 girls and women aged 15 to 25 from 14 countries in North America, Latin America, Europe and the Asia-Pacific region. Cervarix already has approval in more than 90 countries, including the member countries of the European Union, Mexico, Australia, Singapore and the Philippines.
“We are pleased to have reached this significant milestone for Cervarix,” GSK VP and director North American vaccine development Barbara Howe said in a statement. “The data submitted to the FDA reaffirm our confidence in the vaccine’s safety and efficacy profile.”
Merck & Co. already has FDA approval for its vaccine, Gardasil (human papillomavirus quadrivalent [Types 6, 11, 16, 18]).