Teva advises FDA not to approve MS drugs yet
Pharmaceutical major, Teva Pharmaceutical Industries has asked the American industry regulator, the US Food and Drug Administration not to approve new MS drugs until they are tested by independent advisers.
Teva's request for not granting approval to MS drugs is against Biogen Idec, which is expecting FDA to take a decision on its application to market a new MS treatment called BG-12. Experts say that the BG-12 pill will be a competitor of injected Copaxone.
In a petition to the US FDA, Teva said that regulator should not grant approval before it refers MS drugs to an advisory committee for evaluation. Advisory committees are sometimes referred for a review on new drug applications in order to provide guidance for the regulator.
The company said that it is essential for the company to listen to the recommendations of the outside advisers before any approval is granted to MS drugs. It said that the review from outside advisers is necessary due to the concerns relating to the risks that have emerged in recent years, including Biogen's own Tysabri MS treatment.
Teva said in its petition that BG-12 "may be associated with other serious safety risks" that includes problems relating to kidney. The company also cited publicly accessible website suggesting BG-12's active ingredient, dimethyl fumarate affected animal's kidneys in studies.