Myotrophin Approved For Compassionate Use In USA

16 June 1996

Patients with amyotrophic lateral sclerosis in the USA should soon be able to gain access to Cephalon and Chiron's Myotrophin (recombinant human insulin-like growth factor-1; somatomedin C), now that the Food and Drug Administration's Peripheral and Central Nervous System Drugs Advisory Committee has recommended approval of the firms' treatment Investigational New Drug application.

In an unusual move, earlier this year the FDA declined to deliver its own verdict on whether early access should be allowed, and instead referred the matter to the Advisory Committee.

As forecast, the panel agreed that Cephalon's 266-patient North American trial (protocol 1200) supported the safety and efficacy of Myotrophin in ALS patients, but they also agreed that a European trial (protocol 1202) did not support these conclusions. The panel said that another trial may be necessary for FDA approval of the drug.

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