UCB announces MHRA approval for UCB’s Zilbrysq

Green light concerns generalised myasthenia gravis therapy

The Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Zilbrysq as an add-on to standard therapy.

Also known as zilucoplan, the drug treats generalised myasthenia gravis (gMG) among adult patients who are anti-acetylcholine receptor (AChR) antibody positive.

Zilucoplan is the first once-daily subcutaneous, targeted peptide inhibitor of complement component 5 (C5 inhibitor) and the only self-administered gMG therapy for use by adult patients with AChR antibody positive gMG.

gMG is a rare autoimmune condition which impacts 15 individuals per every one million people across the UK.

Those living with gMG can experience a variety of symptoms, including severe muscular weakness that can result in double vision, drooping eyelids, difficulty with swallowing, chewing and talking, as well as life-threatening weakness of respiratory muscles.

Nadeem Aurangzeb, Head of Rare Disease at UCB UK, explained: “The approval of zilucoplan for generalised myasthenia gravis is a significant milestone for the rare disease community in the UK.”

He added: “At UCB we are committed to exploring innovative solutions that support people to live their lives free from the burden of their condition and we are proud to deliver a new treatment option for adults living with this rare, life-limiting, and debilitating condition.”

Professor Saiju Jacob, Consultant Neurologist at University Hospitals Birmingham, concluded: “Generalised myasthenia gravis is a highly disabling condition which impacts every aspect of a person’s life. Zilucoplan offers a welcome, new treatment option for people with the potential to make a real improvement in their lives and their experience of the condition.”