AstraZeneca's vandetanib and GSK/XenoPort's Horizant get US approval

7 April 2011

There was good news for UK-headquartered pharma companies - AstraZeneca (LSE: AZN) and GlaxoSmithKline (LSE: GSK), as well as the latter’s partner XenoPort (Nasdaq: XNPT, (which saw its shares rocket 57% to $10 in extended trading yesterday) - with announcements of US Food and Drug Administration approval for each of their investigational drugs.

The FDA cleared AstraZeneca’s vandetanib to treat adult patients with late-stage (metastatic) medullary thyroid cancer who are ineligible for surgery and who have disease that is growing or causing symptoms. The decision follows a positive opinion from an advisory panel late last year (The Pharma Letter December 3, 2010), when it was suggested that the likely trade name for the drug would be Zactima. The FDA extended its review of the product, which had been given orphan drug status, by three months.

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