UCB announces MHRA approval for UCB’s Zilbrysq

UCB announces MHRA approval for UCB’s Zilbrysq I QUANTUNG PHARMA I www.quantung.com

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.”