Biogen’s gains late-year drug approval first for controversially expensive drug
pharmafile | January 3, 2017 | News story | Manufacturing and Production, Sales and Marketing | Biogen, FDA
The FDA squeezed in one last approval before the year ended with the first approval for a drug to treat patients with spinal muscular atrophy (SMA). Biogen has licensed Spinraza from Ionis Pharmaceuticals and it will enter the market with a list price of $125,000 per dose. The drug requires five or six doses in the first year of treatment and thereafter will lower to three doses per year. Any patient will have to continue taking Spinraza for the rest of their lives, meaning the cost of the drug is exceptionally high.
The trials of the drugs were found to improve motor response by 40% and the treatment will be available to treat both adults and child patients. This is a lifeline for children suffering from the disease, which in its most severe form can kill infants before they reach the age of two. It has the capacity to greatly improve the quality of life of those suffering (SMA).
“SPINRAZA offers new hope for the SMA community and exemplifies our mission of applying cutting-edge science to make a meaningful difference in the lives of patients with devastating, life-altering diseases,” said George A. Scangos, CEO at Biogen. “We are humbled and grateful for the commitment of the patients and families who participated in the Spinraza clinical trial program, the tireless efforts of our investigators, and the urgency demonstrated by the FDA in rapidly reviewing and approving this treatment. We also want to acknowledge the important work of our colleagues at Ionis, who initiated this program.”
Biogen has already approached insures about covering the drug and apparently has been met with a positive reaction, though that seemed indicative of the efficacy of the treatment rather than pricing. It is hard to judge the reaction to the pricing but, in the current climate, such an expensive continuous treatment for a lifelong condition will not sit well. The murmurs of discontent will surely increase when it involves younger children and whether they will be able to receive access to the drug.
Ben Hargreaves
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