Amryt Pharma (AMYT ) said the U.S. FDA has now granted the company priority review for Amryt’s New Drug Application (“NDA”) for Oleogel-S10 for the treatment of Epidermolysis Bullosa (“EB”) which was formally accepted by the federal agency on Wednesday afternoon.
Priority Review is granted by the US FDA to applications for medicines that, if approved, would provide significant improvements in the effectiveness or safety of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.
The FDA has set a Prescription Drug User Fee Act target action date, the deadline by which the FDA must review the application, for the Oleogel-S10 NDA of 30 November 2021.
Amryt's lead development candidate, Oleogel-S10, or Filsuvez® is a potential treatment for the cutaneous manifestations of Junctional and Dystrophic Epidermolysis Bullosa (“EB”).
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.
Commenting on this morning’s news Joe Wiley, CEO of Amryt Pharma, stated: “We are very pleased that the FDA has confirmed priority review of our NDA for Oleogel S10.
Confirmation of a target PDUFA date of November 30, 2021 keeps us on track for a potential approval this year. If approved, Oleogel-S10 could potentially be an important treatment option for patients suffering from EB, a serious and debilitating disease for which there are currently no approved treatments and our launch plans for Oleogel-S10 are well advanced.”
View from Vox
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 expands its portfolio’s reach into both existing and new territories.
Both the NDA and priority review from the US FDA marks ‘another important milestone’ as Amryt 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 0.89% higher this morning at 170p immediately following the news.
Reasons to AMYT
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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