Shire gets US FDA fast track designation for lung disease drug

Shire has received fast track designation from the US Food and Drug Administration for a drug for the prevention of chronic lung disease in extremely premature infants.

The company said the fast track designation of SHP607 is supported by pre-clinical data and phase 1 and 2 studies. The FDA's fast track process is designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need but it does not guarantee approval or the timing of any such approval.

Shire’s head of research and development, Howard Mayer, said: "We are pleased to achieve this regulatory milestone as we progress this very important clinical development program.

"There are no approved treatment options for chronic lung disease for premature infants, and we are aiming to change that. We are continuing to advance the SHP607 clinical program, which is well aligned with Shire’s focus on bringing innovative therapies to patients with rare diseases worldwide."

At 1230 BST, the shares were down 0.7% to 4,053p.