- Amryt Pharma new drug application won’t go through advisory committee
- Amryt Pharma boss ‘really pleased’ with FY results, on 18.5% increase in revenue year-over-year
Quick facts: Amryt Pharma PLC
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.
The company has a strong and growing portfolio of commercial and development assets.
07 Jun 2021
( ) said the US Food and Drug Administration had confirmed its New Drug Application (NDA) for Oleogel-S10 does not require an Advisory Committee meeting.
Oleogel-S10 was developed to treat junctional and dystrophic epidermolysis bullosa (EB), where the skin is fragile to even the lightest touch.
It is a rare condition that affects young children and adults and there is currently no approved treatment.
An FDA advisory committee is an independent body that gives direction to the agency over a product applying for approval.
03 Jun 2021
(NASDAQ:AMYT; ) was granted a priority review of its new drug application for Oleogel-S10 by the US Food & Drug Administration with a decision expected on or before November 30.
The watchdog’s fast-track has shortened the regulatory timeline from 10 months to six.
02 Jun 2021
‘s (NASDAQ:AMYT, ) new drug application for its potential treatment for epidermolysis bullosa (EB) has been approved by the US regulator.
The Food and Drug Administration (FDA) accepted Amrty’s application for Oleogel-S10 to be approved as a treatment for cutaneous manifestations of junctional and dystrophic EB, which affects adults and young children and for which there is no currently approved treatment.
04 Mar 2021
() () CEO Joey Wiley tells Proactive it expects to continue strong sales growth for 2021 after reporting a first underlying profit and strong cash flow for the past year.
Wiley says the biopharma company, which acquires, develops and commercializes novel treatments for rare diseases, generated revenue growth of 18.5% to US$182.6M for 2020 from its two products on the market, metreleptin as a supplement for people with leptin deficiency and lomitapide, for adults with a rare cholesterol disorder.
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