EMA panel backs approval of Amgen/AstraZeneca's asthma drug Tezspire; Ultomiris for expanded use
Waldemarus


A committee of the European Medicines Agency (EMA) recommended the approval of Amgen (NASDAQ:AMGN) and AstraZeneca's (NASDAQ:AZN) Tezspire as an add-on maintenance therapy for patients 12 years and older with severe asthma who are inadequately controlled despite high dose inhaled corticosteroids plus another medicinal product for maintenance treatment.

Tezspire was approved in the U.S. in December 2021.
The EMA's Committee for Medicinal Products for Human Use (CHMP) said Tezspire will be available as a 210 mg solution for injection.
The CHMP also issued a positive opinion backing the expanded approval of Ultomiris an add-on to standard therapy for adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive.
GMG is a rare neuromuscular disorder characterized by loss of muscle function and weakness, causing slurred speech, difficulty in eating and requiring assistance in moving, among other things.
Ultomiris â which was inherited by AstraZeneca (AZN) from acquisition of Alexion â was approved by the FDA for the same expanded use in April.
The European Commission (EC) will make a final decision, which generally follows the recommendation of the EMA, on these therapies.