MedImmune discloses Ethyol issues

In its 10-K filed late Tuesday, MEDI said the FDA may withdraw approval of an sNDA for the company's Ethyol thiophosphate cytoprotective agent if the parties do not reach agreement on the design of a new trial. The sNDA for Ethyol to reduce renal toxicity associated with repeated administration of cisplatin in patients with non-small cell lung cancer (NSCLC) received accelerated approval in 1996.

MEDI completed a post-licensure trial to support the accelerated approval in 2001 and submitted the data last year. MEDI said it met with the agency in late January "to discuss the Agency's conclusion that the study did not meet the Accelerated Approval requirement, as well as their request for another trial to be conducted." MEDI also said that "If no agreement can be reached on the design of such a study, there can be no assurances that the FDA will not withdraw approval of Ethyol for the NSCLC indication." ...