- US regulatory approval for Fasenra
- Positive results from late-stage trials
- Shares recover some lost ground
After a string of disappointing clinical trial results which have weighed on AstraZeneca’s (AZN) shares in the last month, the pharmaceutical firm said it has received US regulatory approval for Fasenra, its treatment for a rare disease which causes inflammation of the blood vessels.
Investors welcomed the news, sending the shares up 126p or just over 1% to £119.82, taking year to date gains to 11%, compared with an 8% advance for the blue-chip FTSE 100 index.
Approval from the US FDA (Food and Drug Administration) was based on positive results from the MANDARA late-stage clinical trial which showed nearly 60% of patients achieved remission and 41% of patients stopped taking oral steroids.
WHAT DID THE COMPANY SAY?
AstraZeneca’s executive vice president Ruud Dobber said: ‘Fasenra is already well established for the treatment of severe eosinophilic asthma, and with this approval, physicians in the US will now be able to offer an important new, convenient single monthly subcutaneous injection to their patients with EGPA.
‘Today's news demonstrates the potential of Fasenra to help patients suffering from eosinophilic diseases beyond severe asthma.’
EGPA (eosinophilic granulomatosis with polyangiitis) is a rare immune-mediated inflammatory disease caused by inflammation of small to medium-sized blood vessels.
It is estimated that around 118,000 people suffer from EPGA with approximately 15,000 living with the disease in the US. Fasenra is currently approved in over 80 countries, including the US, EU, Japan, and China and has been prescribed to over 130,000 patients around the world.
