FDA halts clinical trial of ALS drug
LOS ANGELES The Food and Drug Administration has told CytRx to stop its clinical trial of the drug arimoclomol, which is being developed to treat amyotrophic lateral sclerosis, or Lou Gehrig’s disease, because of the need for additional analysis of previous animal studies involving the drug, according to published reports.
CytRx said in a release that it has asked for further clarification from the FDA, and said that “arimoclomol has been shown to be safe and well-tolerated after being administered to about 185 study volunteers.”
ALS is a progressive condition that affects nerve cells in the brain and spinal cord.
Ranbaxy, GSK settle over Imitrex litigation
HARYANA, India Ranbaxy Laboratories has settled litigation with GlaxoSmithKline related to sumatriptan succinate tablets, the generic of GlaxoSmithKline’s drug Imitrex, according to published reports.
The settlement will allow Ranbaxy to exclusively sell the generic for 180 days starting December this year. Under the terms of the settlement, Ranbaxy can distribute a generic version of sumatriptan in 25 mg, 50 mg and 100 mg doses.
Analysts expect the company to make around $100 million in sumatriptan sales in the U.S. during the exclusivity period. Sumatriptan sales in the U.S. are worth $985 million, according to IMS data.
FDA delays Kynapid decision pending final review
VANCOUVER, Canada The Food and Drug Administration has delayed its decision on an application for the heart treatment drug Kynapid, according to published reports. The drug manufacturer Cardiome Pharma and its co-development partner Astellas Pharma US said yesterday that the FDA did not provide an action letter by the expected date of Jan. 19.
The application for Kynapid (vernakalant hydrochloride), based on a five-year clinical development program, was submitted in December 2006. In December 2007, the FDA’s cardiovascular and renal drugs advisory committee voted 6-2 in favor of recommending to the FDA that Kynapid be approved for the rapid conversion of acute atrial fibrillation to sinus rhythm.
“While we look forward to the FDA reaching a decision, we respect their need for additional time to review the Kynapid’s application,” said William Fitzsimmons, senior vice-president for research and development at Astellas.