EU: Rigel And Jazz Among Hopefuls At CHMP

Rigel Pharmaceuticals and Jazz Pharmaceuticals are among the companies that could find out this week whether their new drug applications at the European Medicines Agency are likely to be approved for marketing across the EU. The EMA's key scientific committee, the CHMP, will also consider applications from Roche and Novartis.

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Who'll get what this week at the CHMP?

The European Medicines Agency’s key scientific committee, the CHMP, is considering this week whether to recommend for marketing across the EU new treatments for thrombocytopenia and narcolepsy or obstructive sleep apnea.

The products are Rigel Pharmaceuticals’ thrombocytopenia drug, fostamatinib, and Jazz Pharmaceuticals’ solriamfetol, indicated to improve wakefulness in patients with narcolepsy or obstructive sleep apnea. Marketing authorization applications (MAAs) for the drugs are among the six MAAs that are formally listed as being up for a potential pan-EU marketing recommendation at the latest monthly meeting of the CHMP, which is under way in Amsterdam. Fosatinib and solriamfetol are already approved in the US, as Tavalisse and Sunosi respectively.

Generic deferasirox, for the treatment of chronic iron overload, is also up for an opinion.

The other three MAAs listed as being up for an opinion from the CHMP this week are polatuzumab vedotin, Roche/Genentech’s new orphan drug for treating mature B cell lymphomas that was approved in the US in June as Polivy, and two Novartis products – siponimod, the company's new drug for treating secondary progressive multiple sclerosis that was approved as Mayzent in the US in March, and osilodrostat, the company's potential new treatment of Cushing's syndrome to which Recordati recently acquired the worldwide rights.  (Also see "Third Time Lucky for Roche’s Polivy in Europe? " - Pink Sheet, 12 Nov, 2019.)  (Also see "EU: Stakes High For Novartis At Latest CHMP Meeting" - Pink Sheet, 13 Nov, 2019.)

The CHMP may adopt a positive or negative opinion at this stage or, if issues still remain, it may choose not to adopt an opinion at all. Once adopted, CHMP opinions are forwarded to the European Commission for a final legally binding decision valid throughout the EU.

The November meeting of the CHMP runs from November 11-14. Highlights will be issued on November 15.

Oral Explanations

Opinions could also potentially be adopted on an additional three MAAs that are at the later stages of the review process. They relate to:

• enasidenib, Celgene/Agios Pharmaceuticals' orphan treatment for acute myeloid leukemia. Celgene has worldwide development and commercialization rights for enasidenib, which was approved in the US in August 2017 as Idhifa,  (Also see "More Good News For AML As Pfizer And AbbVie/Roche Drugs Get FDA Okay" - Scrip, 22 Nov, 2018.)

• Achaogen‘s plazomicin, for the treatment of complicated urinary tract infection, including pyelonephritis, the treatment of bloodstream infection, and the treatment of infections due to Enterobacteriaceae. Plazomicin, a next generation aminoglycoside, won only limited US approval in June 2018 as Zemdri; Achaogen subsequently filed for bankruptcy, in April 2019. (Also see "UK Pilots 'Revolutionary And Needed' Antibiotic Payment System" - Scrip, 1 Oct, 2019.)  (Also see "Achaogen Questioning Whether Others Will Pursue LPAD Pathway After Zemdri Misses Out " - Pink Sheet, 26 Jun, 2018.)

• generic clopidogrel/acetylsalicylic acid, indicated for the secondary prevention of atherothrombotic events.

Celgene was scheduled to be called before the CHMP this week to address in person outstanding questions the committee has regarding its applications. The other two sponsors were potentially due to be called. These MAAs are not listed formally as being up for an opinion. However, it is not unheard of for an opinion to be adopted at this stage. 

More Time

Also according to the meeting agenda, Karyopharm and TMC Pharma have requested more time to answer outstanding issues the CHMP has regarding the companies' MAAs for selinexor and tagraxofusp respectively. Both products were originally being reviewed under the EMA's accelerated assessment mechanism but subsequently reverted to standard review timelines. (Also see "EU Accelerated Assessment – Hard To Get, Hard To Keep" - Pink Sheet, 19 Jul, 2019.)

D&A Pharma & Hopveus Re-Examination

There will be some action at the meeting regarding D&A Pharma's request for a re-examination of the negative CHMP decision that was handed down in October for the company’s alcohol dependence treatment, Hopveus (sodium oxybate).  (Also see "First Ebola Vaccine Among Seven Products To Get EMA Nod" - Pink Sheet, 18 Oct, 2019.) The re-examination rapporteurs will be officially appointed and a draft timetable for the re-examination adopted.