Shire rallies on positive HAE drug trial

The company said it will submit a biologics license application for evaluation by the US Food and Drug Administration late this year or early 2018 after the trial showed the drug reduced the monthly attack rate by 87% versus a placebo over 26 weeks in patients 12 years of age or older with hereditary angioedema. This is a rare, genetic disorder estimated to affect about 1 in 10,000 to 1 in 50,000 people worldwide which results in recurrent, localised edema (swelling).

Chief executive officer Flemming Ornskov said: “We are extremely encouraged by these topline phase 3 results.

“We have nearly a decade of experience and a strong portfolio and pipeline in HAE and believe these data demonstrate high potential for transforming the way patients living with this condition are treated.”

Aleena Banerji, M.D., Massachusetts General Hospital, Boston, MA and clinical trial investigator, said: “If approved, lanadelumab may offer patients a long-acting treatment option that significantly reduces HAE attacks when administered subcutaneously as infrequently as every four weeks.”

At 1430 BST, the shares were up 3.7% to 4,904.50p.