Amryt Pharma (AMYT ) announced that the U.S. Food and Drug Administration has accepted the New Drug Application filing for Oleogel-S10, Amryt’s treatment for Epidermolysis Bullosa.
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.
Amryt told investors this afternoon that the FDA has informed the group that notification of any filing review issues, including priority review determination and the Prescription Drug User Fee Act (“PDUFA”) target action date for the NDA, will be provided by 12 June 2021.
The anticipated launch of Oleogel-S10 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.
Following the success of the trial, Amryt told investors that it was set on completing its submission of its rolling NDA to the US FDA and requested a priority review for Oleogel-S10.
Joe Wiley, CEO of Amryt Pharma, commented: “We are very pleased with the FDA’s acceptance of our NDA for Oleogel-S10 as a potential treatment for EB and we look forward to continuing to work closely with the FDA throughout the review process.”
He added, “Today’s news is also significant for patients. If approved, Oleogel-S10 could potentially be an important treatment option for those suffering from this devastating condition.”
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Today’s news follows a recent string of successes, including Amryt receiving validation for its marketing authorisation application by the European Medicines Agency for Oleogel-S10 in March 2021, as it further expands its portfolio’s reach into both existing and new territories.
The acceptance of the NDA from the US FDA marks ‘another important milestone’ as the group progresses Oleogel-S10 with the regulatory authorities in both Europe and the US.
Shares in Amryt Pharma have increased by over 4% in value since the beginning of 2021. The stock was trading 3.25% higher this afternoon at 174.5 immediately following the news.
Reasons to AMYT
Leading Intellectual Portfolio
Amryt’s portfolio includes its lead development candidate, Oleogel-S10, 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 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.
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®.
Positive 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.
Wiley attributes the strength of AMYT’s FY20 results to the ‘significant operational progress’ it has achieved in an ‘exciting development pipeline’ of new therapeutic drug candidates.
“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 noted.
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.
Amryt said it has infrastructure in place to continue to grow its existing commercial products, adding that it will be able to leverage these capabilities to launch Oleogel-S10.
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