BRIEF — Shire scores new filing acceptance for lanadelumab

Switzerland’s regulator has followed in the footsteps of the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), Health Canada and Australia’s Therapeutic Goods Administration by accepting Shire’s submission for lanadelumab.

The Swiss Agency for Therapeutic Products (Swissmedic) has validated the Marketing Authorization Application (MAA) for the investigational hereditary angioedema (HAE) treatment.

Swissmedic has also handed lanadelumab orphan drug status.

HAE is a rare, genetic disorder estimated to affect about one in 10,000 to one in 50,000 people worldwide.

Andreas Busch, head of research and development at Shire, said: “Today’s announcement represents another important step forward as we continue our work to make lanadelumab available to the global HAE community.

“For those living with HAE, the recurring attacks of swelling can be debilitating. Lanadelumab, if approved, has the potential to change the HAE treatment landscape by directly targeting plasma kallikrein to inhibit excessive bradykinin formation, which stops the blood vessel permeability that causes these swelling attacks.”