Shire Pharmaceuticals gets regulatory approval for one new drug, but fails with another

Shire Pharmaceuticals has received regulatory approval from the US Food and Drug Administration (FDA) for one new drug it has developed, but has failed to achieve the same result with another new treatment.

Phase II trials of SHP625, a drug the company has created to treat the genetic disease Alagille syndrome, did not achieve desired results during a 13-week trial involving 20 children, meaning it has not been given the green light by the FDA for further investigation.

However, tests involving lifitegrast, a drug Shire has developed to combat dry eye disease in adults has received approval from the FDA for more research, as well as a priority review conducted by the national organisation. In line with the rules surrounding such investigations, Shire should know by October 25th this year whether or not the drug can be manufactured for widespread use.

Philip Vickers, head of research and development at the pharmaceutical firm, commented: "Our commitment to moving lifitegrast forward reflects our intent to grow in the ophthalmics therapeutic category in areas of unmet patient need. We look forward to working closely with the FDA throughout the review process."