Earlier this year, the U.S. Food and Drug Administration, medical authorities in the E.U. and Health Canada approved the controversial asthma drug, Xolair, for the treatment of hives, or urticara, a painful skin condition marked by pink, itchy rashes. This drug has been implicated in an increased risk of suffocation from anaphylaxis (a blockage of the air passage caused by throat swelling among other side effects). Drug makers Genentech and Novartis are finding that approval for this purpose in Great Britain is not quite as easy, however.
Xolair is a lucrative product, generating $613 million in global sales outside the U.S. as a treatment for asthma alone – and sales for the treatment of hives could increase that amount by another half billion. Novartis CEO David Epstein announced at a health care conference earlier this year that the prescriptions for Novartis in the treatment of skin disorders could bring in between $2 and $3 billion in additional revenue for the company.
At the moment, the U.K.'s National Institute for Health and Care Excellence (NICE) is demanding that Novartis provide more data on the drug's use in pediatric dermatology.
In the wake of reports of Xolair's potentially deadly side-effects, the FDA started requiring product label warnings in September. Aside from this, one of the concerns is cost: a 24-week course of treatment with Xolair in the U.K. costs the equivalent of $4,700 (USD). Novartis and Genentech have until December 9 to respond to the British health authority's request.