GlaxoSmithKline said the FDA has approved its advanced breast cancer treatment Tykerb (lapatinib). Tykerb is developed for use in combination with Roche’s Xeloda for the treatment of patients with advanced or metastatic breast cancer who haven’t responded to other drugs including Genentech’s Herceptin, which is also marketed by Roche in overseas markets. Approval of Tykerb was granted following a six-month priority review. Analysts expect annual sales of the drug to reach $1 billion by 2010. Treatment with Tykerb will cost around $2,900 a month, Glaxo said in a published report. GlaxoSmithKline said it is also studying the drug for the treatment of earlier-stage breast cancer and head and neck cancers.
The FDA granted Johnson & Johnson’s antibiotic Levaquin an additional six months of marketing exclusivity based on trials showing the drug’s effectiveness in children. The action extends the US patent covering Levaquin from December 2010 to June 2011. J&J said the decision was based on five company-sponsored pediatric studies conducted at the request of the FDA.
Mylan Laboratories has won tentative approval from the FDA to sell a generic version of Abbott Laboratories’ extended-release version of Depakote (divalproex sodium). The FDA granted tentative approval for Mylan to copy the 250 mg and 500 mg versions of Depakote. Under the tentative approval, Mylan must wait until the drug’s patents and market exclusivity of other generics to expire before it can begin selling its generic versions of the drug. Abbott has US patent protection on Depakote until January 2008. In January, Israeli drug maker Teva also received tentative FDA approval generic versions of Depakote for the same strengths plus a 125 mg strength. US sales of Depakote in its 250 mg and 500 mg doses reached approximately $698 million during 2006, according to data from IMS Health. Abbott reported total US sales of Depakote at $1.2 billion last year. Depakote is approved to treat manic episodes in patients with bipolar disorder and certain types of epilepsy and to prevent migraine headaches in adults.
Alexion Pharmaceuticals has received marketing approval from the FDA for Soliris (eculizumab). Soliris is the first therapy approved for paroxysmal nocturnal hemoglobinuria (PNH), a rare, disabling and life-threatening blood disorder defined by chronic red blood cell destruction, or hemolysis. Soliris is indicated for the treatment of patients with PNH to reduce hemolysis.
Shire announced the availability of Lialda (mesalamine) with MMX technology, indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis (UC), a type of inflammatory bowel disease. Lialda is the first and only FDA-approved once daily oral formulation of mesalamine. The FDA approved Lialda in January.
The FDA notified healthcare professionals of new emerging safety concerns about Pfizer’s Zyvox (linezolid) from a recent clinical study. The open-label, randomized trial compared linezolid to rival drugs vancomycin, oxacillin, or dicloxacillin in the treatment of seriously ill patients with intravascular catheter-related bloodstream infections, including those with catheter-site infections. Patients treated with linezolid had a higher chance of death than did patients treated with any comparator antibiotic, and the chance of death was related to the type of organism causing the infection, the FDA said.