Teva Pharmaceuticals on Friday said the US Food and Drug Administration continued to have concerns about its Parkinson’s disease drug Agilect (rasagiline), but the news did little to put investors off, with barely a percentage point wiped off the company’s shares on the day.
The agency has said that the firm’s application is approvable but that there remain a number of undisclosed issues to overcome before it can reach the US market. Teva said it believed it had resolved these with new submissions following a first knock-back in June last year [[06/07/04b]], but the FDA “continues to have concerns” and has indicated its interest in a follow-up meeting. Teva plans to pursue this avenue, adding it: “intends to meet promptly with the FDA and to work closely with the agency to resolve these issues.”
The Israeli company is hoping to win clearance for Agilect as a monotherapy for use in the treatment of early PD and as adjunct therapy to the traditional PD drug, levodopa, in the moderate-to-advanced stages of the disease. Clinical trials have shown Agilect differs from earlier drugs in its class as it offers greater potency and the potential for once-a-day dosing [[10/09/03d]].
Teva has signed a deal with Eisai to co-promote Agilect in the USA [[15/05/03e]]. The compound is already available in the UK, its first market, where it is partnered with Lundbeck and available as Azilect [[28/06/05e]].