Regulation - Approvals

Arrowhead gains UK marketing authorisation for Redemplo

Arrowhead Pharmaceuticals has received marketing authorisation from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for Redemplo (plozasiran) as an adjunct to diet to reduce triglyceride levels in adults with familial chylomicronaemia syndrome (FCS).

MSD’s Keytruda and Padcev combination receives EC approval

The European Commission (EC) has approved Merck & Co’s (MSD) Keytruda (pembrolizumab) plus Padcev (enfortumab vedotin-ejfv) as perioperative treatment for resectable muscle-invasive bladder cancer (MIBC) in adults.

FDA approves Cosette’s Evoxac oral solution for Sjögren’s disease

The US Food and Drug Administration (FDA) has granted approval for Cosette Pharmaceuticals’ Evoxac oral solution to treat dry mouth symptoms in adults diagnosed with Sjögren’s disease.

FDA approves Viatris’ Ryzumvi for adult presbyopia

The US Food and Drug Administration (FDA) has approved Viatris’ Ryzumvi (phentolamine ophthalmic solution 0.75%) to treat presbyopia in adults.

China’s NMPA clears Foresee’s Camcevi 42 mg for prostate cancer

China’s National Medical Products Administration (NMPA) has approved the marketing authorisation application (MAA) for Foresee Pharmaceuticals’ Camcevi 42 mg to treat adult patients with advanced prostate cancer.

FDA approves expanded indication for Lilly’s Jaypirca

The US Food and Drug Administration (FDA) has approved an expanded indication for Eli Lilly and Company’s Jaypirca (pirtobrutinib) as a first-line treatment for adults with previously untreated chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) who do not have a 17p deletion.

Bristol Myers Squibb secures expanded US approval for Camzyos

The US Food and Drug Administration (FDA) has expanded the approved indication for Bristol Myers Squibb’s (BMS) Camzyos (mavacamten) to treat symptomatic obstructive hypertrophic cardiomyopathy (oHCM) in adults and paediatric patients weighing at least 30kg (66lb).

FDA approves Lilly’s Onswik for type 2 diabetes in adults

The US Food and Drug Administration (FDA) has approved Eli Lilly and Company’s Onswik (insulin efsitora alfa-gobe), a once-weekly basal insulin injection for adults with type 2 diabetes (T2D).

EC approves Menarini and NewAmsterdam’s obicetrapib therapies

The European Commission (EC) has granted marketing authorisation to NewAmsterdam Pharma and Menarini Group for Ubeslo (obicetrapib 10mg monotherapy) and Evlarco (10mg obicetrapib plus 10mg ezetimibe fixed-dose combination).