Shire Receives European Approval for TAKHZYRO (lanadelumab) subcutaneous injection

Shire (LSE:SHP, NASDAQ:SHPG), the leading global biotechnology company focused on rare diseases, today announced that the European Commission (EC) has granted Marketing Authorisation for TAKHZYRO™ (lanadelumab) subcutaneous injection, for routine prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 12 years and older.

As quoted in the press release:

TAKHZYRO is a first-of-its-kind fully human monoclonal antibody (mAb) that inhibits the activity of plasma kallikrein, an enzyme which is uncontrolled in people with HAE, to help prevent attacks. HAE is a rare, genetic and potentially life-threatening disorder that can result in recurrent attacks of oedema (swelling) in various parts of the body.

“We are delighted to receive today’s European approval. For those with HAE, the burden of disease can significantly impact their day to day life,” said Andreas Busch, Ph.D., Executive Vice President, Head of Research and Development at Shire, “With TAKHZYRO, we can now provide an innovative treatment that has potential to change the way HAE is currently treated.”

The recommended starting dose is 300 mg lanadelumab every two weeks. In patients who are stably attack free on treatment, a dose reduction of 300 mg lanadelumab every four weeks may be considered, especially in patients with low weight.

Click here to read the full press release.