Insmed drug OK'd for ALS patients, new trial

The FDA and Insmed have hammered out a deal that will allow a limited number of patients with Lou Gehrig's disease to receive doses of Iplex. That drug is approved for growth hormone deficiency but isn't marketed due to a patent dispute involving Genentech.

The use of Iplex for amyotrophic lateral sclerosis--or ALS--was spurred by a raft of urgent requests from doctors whose patients have been desperately seeking a therapy that could help them. And the requests have piled up in recent months despite the fact that similar drugs have failed to demonstrate efficacy.

Now Insmed and the agency have agreed to use limited supplies of the drug to treat specific patients who had made their plea ahead of March 6. And other patients will have a chance to be selected for a new trial to evaluate Iplex's safety and effectiveness. 

There's a good scientific case to make for Iplex. The drug spurs the growth of neurons in the nervous system and the disease leads to the loss of muscle control. Researchers at Insmed are already testing the drug for muscular dystrophy, which also involves the body's muscles.

- read the report from Dow Jones