Please login to the form below

Not currently logged in
Email:
Password:

FDA turns down Celgene’s filing for multiple sclerosis drug

The application needs additional pharmacology information according to the US agency

Celgene

Celgene is facing a delay for its multiple sclerosis candidate ozanimod in the US and elsewhere as the FDA has refused to accept its marketing application for the drug.

The embarrassing setback has arisen because of deficiencies in the “nonclinical and clinical pharmacology sections” of Celgene’s new drug application (NDA) for ozanimod, considered to be one of the most promising candidates in its pipeline.

The company has said it intends to meet with the FDA as soon as possible to decide how to proceed with the application, and is also “re-evaluating the timing of other worldwide regulatory filings” for ozanimod.

The drug is an S1P1/5 receptor modulator in development as a treatment for relapsing-remitting forms of MS, and has been predicted to make rapid headway in the market if approved, thanks to once-daily oral dosing and a benign safety profile. A recent EvaluatePharma reported suggested the drug could achieve sales of around $1.8bn in 2022.

Ozanimod was acquired by Celgene as part of its $7.2bn takeover of Receptos in 2015, part of a drive to expand its business beyond cancer, a view reiterated by Celgene chief executive Mark Alles on a conference call yesterday evening when he said the drug is an important part of the company’s “diversification and growth strategy”.

The efficacy of the drug had been demonstrated by two phase III trials comparing it to Biogen’s injectable interferon beta therapy Avonex, said Alles, who said the company “remains confident” in its profile in relapsing-remitting MS. The FDA’s refusal-to-file (RTF) letter focuses on other elements of the dossier which were “insufficient to allow a complete review”.

“Obviously we are very disappointed, but I believe that at this time we understand the FDA’s position and what we need to do,” he continued. The drug’s second clinical programme in ulcerative colitis is not expected to be affected by the latest regulatory decision.

The company said on the call they did not think the FDA’s position related to safety issues with the S1P class. So far there is just one S1P modulator - Novartis’ Gilenya (fingolimod) - on the market. Gilenya has some off-target effects, such as slowing of the heart that requires monitoring on first dosing, and has been linked to liver function abnormalities.

Celgene has had a difficult few months, with the latest knock coming after its blood cancer blockbuster Revlimid (lenalidomide) failed to hit the mark in non-Hodgkin’s lymphoma, the failure of Crohn’s disease candidate GED-0301, and lacklustre data for psoriasis therapy Otezla (apremilast) in ulcerative colitis.

The company has responded to the difficult period with the $9bn acquisitions of Juno Therapeutics - giving it a stake in the emerging CAR-T cancer immunotherapy market - as well as paying $7bn for Impact Biomedicines to add late-stage candidate fedratinib for myelofibrosis and polycythemia vera.

Article by
Phil Taylor

28th February 2018

From: Regulatory

Share

Tags

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
IGNIFI

We’re IGNIFI. An independent creative agency, we help spark and sustain successful brands for some of the biggest names in...

Latest intelligence

PM Society Digital Awards – the power of together
Our chief executive, Emma Statham, writes about the value of awards and the power of together....
Seduction_feature_image_thumb.jpg
Seduce anyone in four simple steps
You know the health of the global economy is dependent on our ability to seduce one another – don’t you? And you know that we need to be able to...
What Would Jeremy Do? : Assessing the impact of a Corbyn-led Labour government
GK Strategy are delighted to announce the launch our latest briefing paper entitled ‘What Would Jeremy Do? Assessing the impact of a Corbyn-led Labour government’....

Infographics