Amryt receives approval for Myalepta® in England and Wales
(AMYT ) has received reimbursement approval from the National Institute for Health and Care Excellence (“NICE”) for its leptin replacement therapy Myalepta® (metreleptin) in England and Wales.
The biopharmaceutical company focused on developing novel therapeutics to treat serious and life-threatening rare diseases said Myalepta® has now been approved for the treatment of partial and generalised lipodystrophy in adults and children 12 years of age and above.
Generalised and partial lipodystrophy are rare disorders which result in loss or lack of adipose tissue resulting in the deficiency of the hormone leptin. It is associated with severe metabolic abnormalities including severe insulin resistance and hypertriglyceridemia.
Myalept® / Myalepta® (metreleptin) is already approved in the US (under the trade name Myalept®) as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy (GL).
It is approved in the EU to treat leptin deficiency in patients with congenital or acquired GL in adults and children two years of age and familial or acquired partial lipodystrophy in adults and children 12 years of age and above for whom standard treatments have failed to achieve adequate metabolic control. It is also approved for lipodystrophy in Japan.
“We are very excited to report NICE’s approval of Myalepta® which will now give all England and Wales based patients suffering from lipodystrophy the opportunity to access Myalepta®. Today’s news represents further progress in our efforts to grow the geographic reach of our commercial products in both existing and new territories,” said CEO, Dr Joe Wiley.
Rebecca Sanders, Chief Executive of Lipodystrophy UK, commented this morning that, “Lipodystrophy UK are ecstatic that NICE has approved metreleptin for the treatment of partial and generalised lipodystrophy. Lipodystrophy UK will continue to advocate for our community to ensure better treatment and care for everyone affected by lipodystrophy.”
Prof. Sir Stephen O'Rahilly, Director, MRC Metabolic Diseases Unit, University of Cambridge and Hon. Consultant Physician, Addenbrooke's Hospital said, “Patients with lipodystrophy can suffer severe metabolic complications as a result of being deficient in the fat cell hormone, leptin. I am delighted that metreleptin, currently the only form of leptin replacement therapy, will now be available as a treatment for appropriate NHS patients with lipodystrophy.”
Investors will be pleased to add England and Wales to the growing list of countries that have already approved Myalepta® and the industry recognition approval from NICE brings. Patients with insulin resistance, diabetes, hypertriglyceridemia and fatty liver disease even more so. Shares in Amryt Pharma have performed strongly over the past year increasing from 118p to 52 wk highs of 218p in October. Shares opened 0.51% higher this morning at 196p.
Reasons to Follow AMYT
Amryt is a biopharmaceutical company focused on developing and delivering innovative new treatments to help improve the lives of patients with rare and orphan diseases. Amryt comprises a strong and growing portfolio of commercial and development assets.
Leading Portfolio
AMYT’s portfolio includes Amryt's lead development candidate, FILSUVEZ®, a potential treatment for the cutaneous manifestations of EB, a rare and distressing genetic skin disorder affecting young children and adults for which there is currently no approved treatment.
Amryt continues to grow its existing commercial products while it is currently preparing for the launch of its FILSUVEZ® skin product in the US in 4Q21 and in Europe in 1Q22.
The anticipated launch of FILSUVEZ® follows recent positive results from Amryt’s Phase 3 EASE trial, the largest ever global Phase 3 trial conducted in patients with genetic skin disorder Epidermolysis Bullosa (EB), which was performed across 58 sites in 28 countries.
Amryt now intends to complete the submission of its rolling New Drug Application (“NDA”) to the US Food and Drug Administration (“FDA”) and request priority review for FILSUVEZ®.
In a recent report, CEO,Wiley, highlighted the group’s products metreleptin and lomitapide as delivering growth across revenue, EBITDA, cash generation and market expansion.
Amyrt’s Myalept® / Myalepta® injection is a leptin replacement therapy used with a doctor-recommended diet to treat problems caused by not having enough leptin in the body. It is approved in the US under the trade name Myalept® and in the EU under Myalepta®.
Juxtapid®/ Lojuxta® (lomitapide) is approved as an adjunct to a low-fat diet and other lipid-lowering medicinal products for adults with the rare cholesterol disorder, Homozygous Familial Hypercholesterolaemia ("HoFH") in the US, Canada, Columbia, Argentina and Japan under the trade name Juxtapid® and in the EU under the trade name Lojuxta®.
New Distribution Partner
Amyrt recently signed a distribution agreement with Swixx BioPharma AG (“Swixx”), a Swiss pharmaceutical agent operating in Central and Eastern Europe (“CEE”) for Lojuxta®.
The agreement represents new territories for the Group to further accelerate its revenue growth, augmenting sales already being generated through its existing salesforce in the EU.
Strong Outlook
Amryt is well positioned in the novel therapeutics market and strong momentum achieved in the year to date has prompted management to upgrade its guidance for FY20 by around 5% to be in the range of $180m-$182m compared to prior guidance of $170m -$175m.
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