FDA accepts approval application for Teva’s Neutroval
JERUSALEM The Food and Drug Administration has accepted a regulatory approval application from Teva Pharmaceutical Industries for a follow-on biologic, the generic drug maker announced Tuesday.
Teva submitted the application to the FDA on Nov. 30 for XM02, a biosimilar of Amgen’s Neupogen (filgrastim) that Teva plans to market under the name Neutroval.
The drug is used to treat chemotherapy patients experiencing severe neutropenia and febrile neutropenia, a reduction in the number of white blood cells that can result from cancer and chemotherapy.
Teva received approval in the European Union for the drug in September 2008, where it is marketed under the name TevaGrastim. The United States lacks a regulatory approval pathway for biosimilars, requiring Teva to seek regulatory approval using the same process that it would for a novel biologic. Currently, Sandoz’s Omnitrope (somatropin [rDNA origin]), a biosimilar of Pfizer’s growth-disorder treatment Genotropin, is the only biosimilar available in the United States, having received special FDA approval in 2006.
Watson to become commercial partner for emergency contraceptive
MORRISTOWN, N.J. Watson Pharmaceuticals and HRA Pharma have signed a deal whereby Watson will become the commercial partner for an emergency contraceptive undergoing regulatory review by the Food and Drug Administration, Watson announced Monday.
Watson and HRA signed the agreement for ulipristal acetate, also known as UPA, which HRA has marketed in Europe under the EllaOne brand since October 2009. According to data published in a recent issue of medical journal The Lancet comparing the drug with levonorgestrel in 1,696 women in the United States, Ireland and the United Kingdom, UPA provides emergency contraception effectively for up to five days after unprotected sex. Duramed Pharmaceuticals markets levonorgestrel under the Plan B brand, and Watson markets a generic version.
Under the terms of the agreement, Watson will make milestone payments to HRA and royalties on U.S. sales while taking responsibility for commercialization and marketing expenses.
“The opportunity to collaborate with HRA Pharma on the U.S. commercialization of UPA fits nicely within our broader strategy to expand our emerging position in women’s health care and to provide women with a vast array of safe, effective treatment options in contraception as well as other important therapeutic areas,” Watson EVP global brands Fred Wilkinson said. “The published clinical results are significant, and we are optimistic about the prospects of providing U.S. women with a new emergency contraceptive option.”
FDA approves expanded use of breast cancer drug
PHILADELPHIA The Food and Drug Administration has given an additional approval to a breast cancer drug made by GlaxoSmithKline, GSK announced Friday.
The FDA approved Tykerb (lapatinib) combined with Novartis’ Femara (letrozole) as an all-oral, first-line treatment for postmenopausal women with hormone receptor-positive metastatic breast cancer that overexpresses the HER2 protein. HER2 is involved in normal cell growth, but can contribute to cancer when found on cancer cells, and between 25% and 30% of breast cancers overexpress the protein; 60% to 70% of breast cancer cases in the United States and Europe are hormone receptor-positive.
“This combination of Tykerb plus Femara is an example of advancing science and improving patient care,” GSK Oncology research and development SVP Paolo Paoletti said. “This regimen attacks two specific receptors that drive cancer growth. Women battling this disease now have the opportunity to delay the use of traditional cytotoxic chemotherapy, which is an exciting possibility for them.”
Tykerb already had approval as a combination with Roche’s Xeloda (capecitabine) chemotherapy in patients with HER2 advanced or metastatic breast cancer who had received prior therapy with anthracycline chemotherapy and Genentech’s Herceptin (trastuzumab). So far, however, Tykerb combined with Femara — or any other drug belonging to Femara’s class, known as aromatase inhibitors — has not been compared with a treatment regimen based on Herceptin and chemotherapy.