US Approval For Zomig Tablets

The US Food and Drug Administration has granted marketing approval forZeneca's new migraine drug Zomig (zolmitriptan). The approval is key to the commercial success of the 5-HT1B/ID agonist, as the US market represents over 40% of the global sales of migraine drugs in 1996, at over $630 million. Analysts predict sales of around $400 million by 2001, although this could increase if Zeneca engages in direct-to-consumer advertising of the product.

Zomig was launched earlier this year in the UK, Sweden, Germany, Finland and Denmark, and approval has been granted in 12 other countries, including France, Italy and Spain. The product will take on competitor Imigran (sumatriptan) from Glaxo Wellcome, but it has reached the US market ahead of GW's follow-up to Imigran, Naramig (naratriptan). Competition in the market looks set to increase markedly, with similar agents from Merck & Co, Pfizer and SmithKline Beecham nearing the registration phase (Marketletters passim).

Zeneca highlighted the development of an intranasal form of Zomig in its R&D update on December 1 (see pages 24-26, and story below).