Eisai’s severe sepsis drug fails in trial
WOODCLIFF LAKE, N.J. — Eisai will not seek regulatory approval for a drug to treat severe sepsis after getting lackluster results from a late-stage clinical trial, the drug maker said Tuesday.
Eisai said a phase-3 trial of the drug eritoran found the drug did not significantly reduce mortality in patients with the condition compared with placebo.
Severe sepsis causes about 215,000 deaths in the United States every year, with a mortality rate of about 30%.
In other news, however, the company said it would file for approval of perampanel, a drug for epilepsy, following more promising results from a phase-3 trial.
Teva receives FDA action letter for generic Lovenox
JERUSALEM — Teva on Tuesday confirmed its receipt of an action letter from the Food and Drug Administration for its generic blood-thinning drug.
The drug maker said the FDA sent a minor deficiency letter, which indicated the regulatory agency completed its review of the abbreviated new drug application for generic Lovenox (enoxaparin sodium) injection, as well as Teva’s responses to key questions during the review process. Prior to potential final product approval, Teva also needs to respond to questions posed by the Office of Generic Drugs, which the drug maker said it will answer in the near future.
Lovenox, designed to treat deep vein thrombosis, is made by Sanofi-Aventis.
Mylan announces Lipitor, Caduet patent settlements
PITTSBURGH — Generic drug maker Mylan has entered settlements with Pfizer concerning two drugs for treating cholesterol.
Mylan announced Tuesday that it had settled patent litigation suits with Pfizer concerning Lipitor (atorvastatin calcium) and Caduet (atorvastatin calcium and amlodipine besylate).
Under the Caduet agreement, the lawsuit will be dismissed, and Mylan can launch its generic version on Nov. 30. Terms of the Lipitor agreement remain confidential.
Caduet had sales of $389 million during the 12-month period ended in September 2010, according to IMS Health, while Lipitor had sales of $7.27 during the same period.