Orchard’s Gene Therapy Under Fast-Track Review At EMA

A handful of new products are under review at the European Medicines Agency. Orchard Therapeutics' gene therapy application will be fast-tracked; Roche's filing for its new flu treatment will not.

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Some new products are under the microscope at the EMA

Orchard Therapeutics’ gene therapy for metachromatic leukodystrophy, OTL-200, and Roche’s new influenza drug, Xofluza (baloxavir marboxil), are among the new marketing authorization applications (MAAs) that have been accepted for review at the European Medicines Agency.

Other applications that are newly under assessment for potential approval throughout the EU include:

• QVM149, Novartis’s triple combination of indacaterol, glycopyrronium and mometasone that the company is developing as a once-daily inhaled therapy for uncontrolled asthma. (Also see "Novartis Primed To Re-Energize Respiratory Business, Rivals Close In" - Scrip, 2 Oct, 2019.)

• Amarin Corp’s cardiovascular treatment Vascepa (icosapent ethyl). (Also see "Vascepa Gains European Filing Nod" - Scrip, 2 Dec, 2019.)

• Janssen’s investigational two-dose Ebola vaccine regimen. (Also see "Another Ebola Vaccine Among New Filings At EMA " - Pink Sheet, 8 Nov, 2019.)

The EMA’s latest list of MAAs under review was compiled on 2 December. It includes information only for medicines whose applications have been validated at the time the report was compiled.

Orchard Therapeutics Ltd.’s OTL-200 is being reviewed under the EMA’s accelerated assessment mechanism, which reduces the time it takes the agency to evaluate an MAA from 210 days to 150 days (not counting clock stops when applicants have to provide additional information). Janssen’s two MAAs for its Ebola vaccine also have fast-track status. Roche had applied for fast-track review for Xofluza but its request appears to have been rejected. The product is listed as being under standard review.

The final new MAA on the EMA list is for a product with orphan status containing potassium citrate/potassium hydrogen carbonate.

Details of these latest applications will be added to the Pink Sheet's New Filings at the EMA tracker in due course. The latest update is available here.