SUPPLIER NEWS — A drug under development by Forest Labs and Pierre Fabre has been shown to reduce symptoms of major depressive disorder, the companies said. New York-based Forest and Paris-based Pierre Fabre announced results of a phase-3 trial of levomilnacipran, saying the drug showed reductions in symptoms as early as one week after treatment was started. The companies expect results of another phase-3 trial of the drug this spring.
A new drug for Type 2 diabetes made by Eli Lilly and Boehringer Ingelheim is available in pharmacies, the companies said. The two companies announced the availability of Jentadueto (linagliptin and metformin hydrochloride). The FDA approved the drug on Jan. 30.
The companies developed the drug under a partnership started last year that resulted in a dispute between Lilly and Amylin Pharmaceuticals, with which Lilly had developed the injected Type 2 diabetes drugs Byetta (exenatide) and its long-acting version, Bydureon, which the FDA also approved on Jan. 30. Lilly and Amylin terminated their agreement in November.
The Food and Drug Administration has declined to approve a drug made by Eisai for leukemia in certain elderly patients, the drug maker said. Eisai said the FDA delivered a complete response letter for the chemotherapy drug Dacogen (decitabine) in patients ages 65 years and older with acute myeloid leukemia who are not candidates for induction therapy. The FDA delivers a complete response letter when questions remain about a regulatory application that preclude approval.
The drug maker said the FDA’s decision was due to the primary study not providing convincing evidence of safety and effectiveness for AML. The drug already is approved for treating myelodysplastic syndromes, a group of cancers that result from damage to the cells in the bone marrow that form blood cells.