GCIAmryt submits New Drug Application to US FDA for Oleogel-S10
London-listed (AMYT ) has confirmed to investors that it has submitted a New Drug Application (“NDA”) to the U.S. Food and Drugs Administration (“FDA”) for Oleogel-S10.
Amryt's lead development candidate, Oleogel-S10, or Filsuvez® is a potential treatment for the cutaneous manifestations of Junctional and Dystrophic Epidermolysis Bullosa (“EB”).
EB is a rare and distressing genetic skin disorder affecting young children and adults for which there is currently no approved treatment. Filsuvez®, which has been selected as the brand name for Oleogel-S10, does not currently have regulatory approval to treat EB.
The NDA submission, which the group says is an “important milestone” in its efforts to progress Oleogel-S10 in the US and Europe, includes a request for Priority Review which can expedite the review process to six months following acceptance of the NDA submission.
Previously Oleogel-S10 has been granted Orphan, Fast Track and Pediatric Rare Disease designation by the FDA and the rolling submission of the NDA began on 29 June 2020.
Based on US FDA timelines, Amryt informed investors that it expects to receive notification if Priority Review has been granted and if the NDA has been accepted for filing in Q2 2021.
The NDA is supported by data from the EASE pivotal phase 3 trial in EB (“EASE”), the largest ever global Phase 3 trial for EB. The study met its primary endpoint of accelerated healing of the target wound by day 45 in patients treated with Oleogel-S10 vs a control gel.
“Our NDA submission to the FDA marks another important milestone for Amryt as we progress our lead development candidate Oleogel-S10 with the regulatory authorities in both the US and Europe,” commented Dr Joe Wiley, Chief Executive of Amryt Pharma.
Wiley said that today’s news, in addition to Amryt’s recent validation of its MAA for Oleogel-S10 by the European Medicines Agency (“EMA”), represent “a potentially important advancement” for patients and families living with this rare and distressing disorder.
He added that the company would “continue to work closely with the respective regulatory authorities with the hope of bringing Oleogel-S10 to patients as soon as possible.”
Today’s news follows a recent string of successes as Amryt expands its portfolio’s reach into both existing and new territories. In particular, it marks ‘another important milestone’ as the group progresses Oleogel-S10 with the regulatory authorities in both Europe and the US.
Last week, the group announced that it had received its marketing authorization application (“MAA”) by the European Medicines Agency (“EMA”) for Oleogel-S10 which confirmed that the company’s application is now sufficiently complete to begin the formal review process.
The EMA review for Oleogel-S10 will include an opinion of the Committee for Medicinal Products for Human Use expected within 210 ‘active’ days. Should a priority review be granted by the FDA and the NDA accepted for filing, this is expected to occur in 2Q21.
Shares in Amryt Pharma have increased by over 8% in value since the beginning of the year. The stock opened flat this morning at 206.5p immediately following the announcement.
Reasons to 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®.
Expanding Distribution Capacity
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.
In recent weeks, Amryt received approval from the National Institute for Health and Care Excellence (“NICE”) for its leptin replacement therapy Myalepta® (metreleptin) in England and Wales, to treat partial and generalised lipodystrophy in adults and children 12+ years of age.
Positive Outlook
Last week, the Company released ‘record’ results for FY20 which it said were demonstrative of ‘the very positive performance and growth’ that its commercial products are delivering.
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. “Given the strong performance of our business in 2020, we are now issuing revenue guidance for FY21 of $200-$205m which demonstrates our confidence in our prospects,” Wiley told investors.
The Group said both metreleptin and lomitapide continue to deliver growth ‘across a host of metrics’ including revenue and EBITDA growth, cash generation and market expansion.
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