As announced by AstraZeneca, the European Medicines Agency’s Committee for Medicinal Products for Human Use bases its recommendation on the approval of the drug on the results of the phase 3 Champion-MG study.
Ultomiris has been recommended as an adjunct to standard therapy for the treatment of adult patients with generalized myasthenia gravis who are anti-acetylcholine receptor antibody positive. Generalized myasthenia gravis is a neuromuscular disorder that results in loss of muscle function and severe weakness.
AstraZeneca compound Tezspire recommended for EU approval
The pharmaceutical company AstraZeneca can hope for approval of the drug Tezspire in the EU for the treatment of severe asthma. Tezspire has been recommended by the European Medicines Agency’s Committee for Medicinal Products for Human Use as add-on therapy for patients aged 12 and over with severe asthma who are inadequately controlled on high-dose inhaled corticosteroids plus another maintenance medicine.
Asthma is a disease that affects around 14 million people in the European Union.
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