EU green light for 10 new medicines – extends the scope of 11 existing products

The European Medicines Agency (EMA) has recommended ten new products for approval at a bumper June meeting which also saw therapeutic extensions granted for eleven drugs. The watchdog’s human medicines committee (CHMP) wrapped up a busy half year in which a total of 57 new medicines were approved, along with new indications for a total of 40 existing products.

The committee recommended authorisation for the following:

Balversa (erdafitinib) for the treatment of adult patients with unresectable or metastatic urothelial carcinoma, a cancer of the bladder and urinary system.

Eurneffy (epinephrine), the first emergency treatment against allergic reactions that is administered as a nasal spray, not as an injection.

mResvia (Respiratory Syncytial Virus (RSV) mRNA vaccine) for prevention in adults 60 years of age and older of lower respiratory tract disease and acute respiratory disease caused by respiratory syncytial virus (RSV). RSV is a common respiratory virus that usually causes mild, cold-like symptoms but can lead to serious consequences in older adults. This is the first mRNA vaccine targeting a different pathogen than SARS-CoV-2 that receives a positive opinion from the CHMP.

Ordspono (odronextamab) received a conditional recommendation for the treatment of follicular lymphoma and diffuse large B-cell lymphoma, two types of blood cancer that affect the immune system.

Piasky (crovalimab) for the treatment of paroxysmal nocturnal haemoglobinuria, a rare genetic disorder that causes the premature breakdown of red blood cells by the immune system and is potentially life-threatening.

Tauvid (flortaucipir (¹⁸F)) for positron emission tomography (PET) imaging of the brain in adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease.

Winrevair (sotatercept) to treat adult patients with pulmonary arterial hypertension, a rare, long-term, debilitating and life-threatening condition in which patients have abnormally high blood pressure in the arteries in the lungs.

Steqeyma (ustekinumab), a biosimilar medicine for the treatment of adult patients with moderate/severe active Crohn’s disease, plaque psoriasis, paediatric plaque psoriasis and psoriatic arthritis.

The committee also adopted positive opinions for two generic medicines: Enzalutamide Viatris (enzalutamide) for the treatment of prostate cancer, and Nilotinib Accord (nilotinib) for the treatment of Philadelphia chromosome positive chronic myelogenous leukaemia.

Extensions of indication were recommended for 11 medicines that are already authorised in the EU: Betmiga, Beyfortus, Cresemba, Imcivree, Imfinzi, Infanrix hexa, Lynparza, Pegasys, Tepkinly, Vabysmo and Xalkori.