LEMS, which causes debilitating muscle weakness, where the immune system attacks the nerves that control the muscles, is so rare, and the drug is so easily available, that it is currently being given away for free in the US by Jacobus Pharmaceuticals.

Catalyst, however, has reported positive results from a phase III study of Firdapse as a treatment for LEMS and intends to seek US Food and Drug Administration (FDA) approval in early 2015. The price hike from Catalyst, once approved, is expected to be in the region of US$80,000.

The whole situation comes as a result of FDA’s 2006 Unapproved Drugs Initiative, which rewards companies for testing treatments that have been on the market for years, but have never been subjected to rigorous trials. FDA’s aim was to get unapproved drugs off the market and to protect patients from potential harm. However, with no authority over pricing, the programme allows drug companies to suddenly increase the price of commonly available drugs.

Other drugs that have already seen a huge increase in price under this initiative include premature birth prevention Makena (hydroxyprogesterone), gout treatment Colcrys (Colchicine), and scorpion antivenom Anascorp (centruroides).

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