Amryt Announces FDA Acceptance of New Drug Application for Oleogel-S10 for the Treatment of Epidermolysis Bullosa
Amryt Announces FDA Acceptance of New Drug Application for Oleogel-S10
Amryt (Nasdaq: AMYT) has announced that the FDA accepted its New Drug Application (NDA) for Oleogel-S10, designed to treat Epidermolysis Bullosa (EB), a severe genetic skin disorder. The acceptance was confirmed on June 2, 2021, with the FDA expected to provide further feedback by June 12, 2021. The NDA is backed by positive data from the EASE Phase 3 trial, the largest study of its kind in EB, indicating potential therapeutic benefits for patients suffering from this condition.
- FDA acceptance of NDA for Oleogel-S10 indicates potential market approval for a new EB treatment.
- Positive results from EASE Phase 3 trial provide strong support for Oleogel-S10's efficacy.
- Oleogel-S10 addresses a significant unmet medical need in the treatment of EB.
- None.
Amryt Announces FDA Acceptance of New Drug Application for Oleogel-S10 for the Treatment of Epidermolysis Bullosa
DUBLIN, Ireland, and Boston MA, June 2, 2021, Amryt (Nasdaq: AMYT, AIM: AMYT), a global, commercial-stage biopharmaceutical company dedicated to acquiring, developing and commercializing novel treatments for rare diseases, today announces that the U.S. Food and Drug Administration (“FDA”) has accepted for filing Amryt’s New Drug Application (“NDA”) for Oleogel-S10 for the treatment of Epidermolysis Bullosa (“EB”). Oleogel-S10 is a potential treatment for the cutaneous manifestations of Junctional and Dystrophic EB, a rare and distressing genetic skin disorder affecting young children and adults for which there is currently no approved treatment.
The FDA has informed Amryt 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 June 12, 2021 (Day 74 post submission date).
The NDA is supported by positive results from Amryt’s pivotal global Phase 3 trial in EB (“EASE”) reported in September, 2020. EASE was the largest ever global Phase 3 study conducted in patients with EB and is the first Phase 3 trial ever to demonstrate positive results in EB.
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. 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.”
About Amryt
Amryt is a global commercial-stage biopharmaceutical company focused on acquiring, developing and commercializing innovative 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.
Amryt’s commercial business comprises two orphan disease products – metreleptin (Myalept®/ Myalepta®) and lomitapide (Juxtapid®/ Lojuxta®).
Myalept®/Myalepta® (metreleptin) is 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) and in the EU (under the trade name Myalepta®) as an adjunct to diet for the treatment of leptin deficiency in patients with congenital or acquired GL in adults and children two years of age and above and familial or acquired partial lipodystrophy (PL) in adults and children 12 years of age and above for whom standard treatments have failed to achieve adequate metabolic control. For additional information, please follow this link.
Juxtapid®/Lojuxta® (lomitapide) is approved as an adjunct to a low-fat diet and other lipid-lowering medicinal productsfor adults with the rare cholesterol disorder, Homozygous Familial Hypercholesterolaemia ("HoFH") in the US, Canada, Colombia, Argentina and Japan (under the trade name Juxtapid®) and in the EU, Israel and Brazil (under the trade name Lojuxta®). For additional information, please follow this link.
Amryt's lead development candidate, Oleogel-S10 (Filsuvez®) is a potential treatment for the cutaneous manifestations of Junctional and Dystrophic Epidermolysis Bullosa (“EB”), a rare and distressing genetic skin disorder affecting young children and adults for which there is currently no approved treatment. Filsuvez® has been selected as the brand name for Oleogel-S10. The product does not currently have regulatory approval to treat EB.
Amryt’s pre-clinical gene therapy platform, AP103, offers a potential treatment for patients with Dystrophic EB, and is also potentially relevant to other genetic disorders.
For more information on Amryt, including products, please visit www.amrytpharma.com.
This announcement contains inside information for the purposes of article 7 of the Market Abuse Regulation (EU) 596/2014. The person making this notification on behalf of Amryt is Rory Nealon, CFO/COO and Company Secretary.
Financial Advisors
Shore Capital (Edward Mansfield, Daniel Bush, John More) are NOMAD and Joint Broker to Amryt in the UK. Stifel (Ben Maddison) are Joint Broker to the company in the UK.
Forward-Looking Statements
This press release may contain forward-looking statements containing the words "expect", "anticipate", "intends", "plan", "estimate", "aim", "forecast", "project" and similar expressions (or their negative) identify certain of these forward-looking statements. The forward-looking statements in this announcement are based on numerous assumptions and Amryt's present and future business strategies and the environment in which Amryt expects to operate in the future. Forward-looking statements involve inherent known and unknown risks, uncertainties and contingencies because they relate to events and depend on circumstances that may or may not occur in the future and may cause the actual results, performance or achievements to be materially different from those expressed or implied by such forward-looking statements. These statements are not guarantees of future performance or the ability to identify and consummate investments. Many of these risks and uncertainties relate to factors that are beyond each of Amryt's ability to control or estimate precisely, such as future market conditions, the course of the COVID-19 pandemic, currency fluctuations, the behaviour of other market participants, the outcome of clinical trials, the actions of regulators and other factors such as Amryt's ability to obtain financing, changes in the political, social and regulatory framework in which Amryt operates or in economic, technological or consumer trends or conditions. Past performance should not be taken as an indication or guarantee of future results, and no representation or warranty, express or implied, is made regarding future performance. No person is under any obligation to update or keep current the information contained in this announcement or to provide the recipient of it with access to any additional relevant information that may arise in connection with it. Such forward-looking statements reflect the Company’s current beliefs and assumptions and are based on information currently available to management.
Contacts
Joe Wiley, CEO / Rory Nealon, CFO/COO, +353 (1) 518 0200, ir@amrytpharma.com
Edward Mansfield, Shore Capital, NOMAD, +44 (0) 207 468 7906, edward.mansfield@shorecap.co.uk
Tim McCarthy, LifeSci Advisors, LLC, +1 (212) 915 2564, tim@lifesciadvisors.com
Amber Fennell, Consilium Strategic Communications, +44 (0) 203 709 5700
FAQ
What is the significance of Amryt's NDA acceptance for Oleogel-S10?
When is the FDA expected to provide feedback on the NDA for Oleogel-S10?
What were the results of the EASE Phase 3 trial for Oleogel-S10?
What condition does Oleogel-S10 aim to treat?
