(Reuters) – A European Medicines Agency (EMA) panel on Friday recommended approving a potential blockbuster drug from Shire Plc to treat patients aged 12 and older with a rare hereditary disease that causes swelling in different parts of the body.
The drug, Takhzyro, which Shire acquired through its $5.9 billion buyout of Dyax in 2016, is expected to generate about $2 billion in peak sales, analysts said.
The recommendation by the EMA’s Committee for Medicinal Products for Human Use (CHMP) will be a shot in the arm for Japan’s Takeda Pharmaceutical Co Ltd, which is waiting for EU antitrust approval to wrap up its $62 billion acquisition of Shire.
The U.S. Food and Drug Administration has already approved the monoclonal antibody, previously known by its chemical name lanadelumab, to treat patients with types I and II hereditary angioedema (HAE).
There are only a handful of treatments available for HAE, which affects people with low levels of a certain protein and results in episodes of severe swelling in stomach, limbs, face and throat. It affects about one in 50,000 people.
While final approvals are up to the European Commission, it generally follows the CHMP’s recommendation and endorses them within a couple of months.
(Reporting by Justin George Varghese; Additional reporting by Sangameswaran S. in Bengaluru; Editing by Anil D’Silva)