NEW YORK (TheStreet) -- Danish pharmaceutical company ALK announced it had received unanimous support from a U.S. Food and Drug Administration (FDA) advisory committee for oral drug Gratsek. The drug, designed to treat glass pollen allergies, is one developed as part of ALK's strategic partnership with Merck & Co. (MRK), a marriage which will grant the latter license to market and sell the product in North American markets.
The FDA said the available data demonstrated Gratsek's efficacy and safety among patients aged five to 65, but recommended further studies related to its use among children aged 11 years and under.
"ALK welcomes the FDA Advisory Committee's conclusion, which represents another important step towards bringing this innovative new treatment to U.S. patients," ALK CEO Jens Bager said in a statement.
The FDA will review Merck's Biologic License Application for Gratsek, taking the advisory committee's opinion into consideration, and the drug's approval could be granted as early as the first half of 2014.Merck shares were off 0.39% to $48.32 by market close. In post-market trading, the stock had regained 0.29% to $48.46. --Written by Keris Alison Lahiff.
Check Out Our Best Services for Investors
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Model portfolio
- Stocks trading below $10
- Intraday trade alerts