AstraZeneca (AZN) said Friday that Alexion, AstraZeneca Rare Disease's Klygefa received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use recommending approval in the European Union.

Klygefa is intended to treat adults with generalized myasthenia gravis, a rare autoimmune disorder characterized by reduced muscle function and severe muscle weakness.

The opinion was supported by data from the phase 3 PREVAIL trial, which the company said demonstrated the efficacy and safety profile of the long-acting C5 complement inhibitor in patients with the disease.

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