Astrazeneca's Ultomiris receives FDA approval

AstraZeneca stated Ultomiris, the first and only long-acting C5 complement inhibitor to demonstrate clinical improvement in patients with generalised myasthenia gravis, received approval from the Food and Drug Administration following positive results from its CHAMPION-MG Phase III trial.

The FTSE 100-listed firm stated trial results indicated that Ultomiris showed early effects and lasting improvements in daily living and that it also held the potential to reduce treatment burden with dosing every eight weeks.

Marc Dunoyer, chief executive officer of AZN's Alexion unit, said: "Since bringing forward the first complement inhibitor, we've continued to listen to the community and focused innovation on the needs of gMG patients. We're proud to deliver on this commitment with today's approval.

"Ultomiris, the only long-acting C5 inhibitor, will benefit a broader range of patients, including those with milder symptoms. As presented at the 2022 American Academy of Neurology Annual Meeting, Ultomiris has demonstrated clinical benefit through 60 weeks, with treatment every eight weeks, compared to Soliris every two weeks."

As of 1010 BST, AstraZeneca shares were 0.29% firmer at 10,542.0p.