Pharmaceutical Business review

BeOne Medicines receives EC approval for Brukinsa tablet formulation

The therapy’s recommended dose remains 320mg daily. Credit: Bruno Guerrero on Unsplash.

Brukinsa’s recommended dose remains 320mg a day. The new tablets, each 160mg, allow patients to halve their intake of daily pill from four to two.

Moreover, these tablets are small in size compared to the capsules and are film-coated, due to which they can be swallowed easily.

BeOne senior vice-president and head of Europe Giancarlo Benelli said: “Developed to meet the real-world needs of patients, the new Brukinsa tablet formulation aims to simplify treatment, reduce pill burden, and enhance ease of administration, reflecting our continuous focus on patient-centred innovation.

“With more than 200,000 patients treated globally and the broadest label of any BTK inhibitor in Europe, Brukinsa’s differentiated clinical profile continues to make an impact for people facing certain B-cell cancers.”

Brukinsa is an orally administered, small molecule inhibitor of Bruton’s tyrosine kinase (BTK), engineered to provide continuous inhibition of the BTK protein. It possesses a distinct pharmacokinetic profile in comparison to other authorised BTK inhibitors.

Its global clinical development programme encompasses around 7,100 subjects across 30 countries and regions, participating in over 35 trials.

The therapy has received approval for at least one indication in more than 75 markets, with over 200,000 patients treated worldwide.

BeOne Medicines, headquartered in Switzerland, is an oncology firm dedicated to the discovery and development of treatments for cancer patients across the globe.

Its portfolio encompasses both haematology and solid tumours, featuring a pipeline of therapeutics developed through in-house expertise and collaborations.