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22 Mar 2021 | 09:04

Amryt's Myalepta gets reimbursement approval in France

(Sharecast News) - Commercial-stage biopharmaceuticals company Amryt Pharma announced on Monday that the French Ministry of Social Affairs and Health has approved 'Myalepta', or metreleptin, for reimbursement in the country as an adjunct to diet as replacement therapy. The AIM-traded firm said the approval was for the treatment of leptin deficiency in patients with congenital or acquired general lipodystrophy in adults and children two years and older, and familial or acquired partial lipodystrophy in adults and children 12 years and older, for who standard treatments had failed to achieve adequate metabolic control.

Myalepta received marketing authorisation from the European Medicines Agency in 2018.

The board said the Haute Autorité de Santé in France had given a favorable opinion for reimbursement in the relevant indications in 2019.

"We are very pleased to report the French Ministry of Social Affairs and Health's approval of Myalepta® which will now give all French patients suffering from lipodystrophy the opportunity to access Myalepta," said chief executive officer Dr Joe Wiley.

"Today's news represents further progress in our efforts to grow the geographic reach of our commercial products in both existing and new territories."

At 0835 GMT, shares in Amryt Pharma were up 1% at 220.18p.
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