Bristol-Myers Squibb’s experimental leukemia drug Sprycel should be approved for patients with few, if any, other leukemia treatment options, an FDA advisory panel said on Friday. The panel agreed that Sprycel reduced or eliminated leukemia cells in some patients who stopped responding to Novartis’ Gleevec or could not tolerate the treatment. Currently, the only option for many patients at that stage is to undergo a risky bone-marrow transplant, if they are eligible. Analysts project annual Sprycel sales of $700 million by 2010. The treatment could become a multi-billion-dollar seller if it proves to be a Gleevec competitor for earlier use in the progression of chronic myeloid leukemia.The FDA usually follows the advice of its advisory panels. A final agency decision is expected by June 28.
BioMarin Pharmaceutical and Alliant Pharmaceuticals said the FDA has approved marketing of Orapred ODT (prednisolone sodium phosphate orally disintegrating tablets), the first-orally disintegrating tablet form of prednisolone available in the US. Alliant expects to begin marketing Orapred ODT in the US in August or September of 2006.
The FDA has approved CollaGenex Pharmaceuticals’ Oracea for the treatment of inflammatory lesions (papules and pustules) of rosacea in adult patients. Oracea is the first FDA-approved, orally-administered, systemically-delivered drug to treat rosacea, a dermatologic condition that affects an estimated 14 million adults in the U.S. CollaGenex plans to launch Oracea to the dermatology community in July 2006.
Celgene Corporation said the FDA has granted accelerated approval to its Supplemental New Drug Application (sNDA) for Thalomid (thalidomide) in combination with dexamethasone for the treatment of newly diagnosed multiple myeloma.
The FDA has approved Allergan’s Juvederm gel family of prescription products for correction of facial wrinkles and folds.