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Shire claims EU approval for haemophilia A drug Adynovi

The drug will battle Bayer’s Kovaltry and Sobi's Elocta in a bid to capture market share


The European Commission has approved Shire’s haemophilia A therapy Adynovi, a new long-acting version of its long-established Advate product.

Adynovi (rurioctocog alfa pegol) has been cleared for on-demand and prophylactic use in haemophilia A patients aged 12 or over and has a pegylated formulation that reduces the frequency of injections from daily to just two per week.

The drug was originally developed by Baxalta, which was acquired by Shire for $32bn in 2016, and was approved for marketing in the US in 2015 under the Adynovate brand name, subsequently picking up additional approvals in Japan, Canada, Switzerland and Colombia.

It is jostling for market share with other long-acting Factor VIII products for haemophilia A, including Bayer’s Kovaltry and Sobi's Elocta and while Shire does not break out figures for individual haemophilia products in its financial results is estimated to have made around $300m last year - or around 10% of its total franchise.

Bayer does not separate Kovaltry from its short-acting predecessor Kogenate but reported combined sales of €750m ($920m) in the first nine months of 2017.

“The European approval of Adynovi is an important milestone in our continued commitment to provide new treatment options for patients living with haemophilia A,” said Peter Foertig, head of haematology medical affairs at Shire.

“We believe that the twice-weekly prophylactic dosing, as well as the on-demand control of bleeding, offered by Adynovi will bring us closer to our goal of improving and personalising disease management for haemophilia A patients in Europe.”

The combined treatment drugs market for haemophilia A and B across seven of the largest pharma markets is expected to reach almost $8bn in 2026, a rise from $6.7bn in 2016, according to figures from GlobalData.

A big part of the increase will be driven by the increased use of long-acting prophylactic injections for clotting factors, although this will be less pronounced in haemophilia A than haemophilia B, mainly because unlike the latter the longer half-life of these drugs do not translate to “a meaningful reduction in dosing frequency”, it says.

Article by
Phil Taylor

15th January 2018

From: Regulatory



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