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 The drugmaker recently completed its $39-billion acquisition of
Alexion, which it had agreed to buy as a bet on rare-disease
immunology and to boost its business that includes a fast-growing
cancer medicines unit and a major COVID-19 vaccine.
AstraZeneca said the drug Ultomiris had been given a positive
opinion for paroxysmal nocturnal haemoglobinuria (PNH) by the human
medicines committee of the EMA, and it follows a U.S. approval in
June.
The EMA endorsement is to include children with a body weight of 10
kg or above, and those patients who are clinically stable after
having been treated with another Alexion drug, Soliris, for at least
the past six months.
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 "The potential approval of
Ultomiris, which offers the efficacy and safety
already established with Soliris (eculizumab)
and requires fewer treatments each year, would
have a meaningful impact for children with PNH
and their families," said Austin Kulasekararaj,
MD at King's College Hospital in London.
Ultomiris is an improved version of Alexion's
best-selling drug Soliris, which is used against
a range of rare immune-disorders including PNH
where the body's immune system attacks its own
red blood cells causing anaemia and blood clots.
(Reporting by Pushkala Aripaka in Bengaluru;
Editing by Ramakrishnan M and Uttaresh.V)
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