Sanofi Seeks Double Vaccine Approval Nod In EU

The sponsors of up to seven new drugs or vaccines will find out this week whether their products will soon be approved in the EU. The products include two vaccines from Sanofi and what is possibly the first generic rival to Bayer's Xarelto to be assessed by the European Medicines Agency.

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Sanofi's meningococcal disease vaccine could be approved in Europe soon

The seven marketing authorization applications (MAAs) that are up for an opinion this week on whether they should be marketed in the EU include two vaccines from Sanofi – one for the prevention of invasive meningococcal disease, including meningitis, and one for flu.

Also up for an opinion is a generic version of rivaroxaban. This appears to be the first generic version of Bayer AG’s blockbuster anticoagulant Xarelto to go through the European Medicines Agency's centralized approval pathway. 

Other MAAs likely to get a decision from the EMA’s drug review committee, the CHMP, relate to obiltoxaximab, for the treatment of inhalational anthrax due to bacillus anthracis, and bupivacaine, for prolonged acute pain management and reduction in need for opioids in adults compared to immediate-release bupivacaine. 

The other two MAAs on which a decision is expected this week are for a generic and a biosimilar. The generic is melphalan, for treating various cancers and for use as a conditioning treatment prior to allogeneic hematopoietic stem cell transplantation in hematological diseases. The biosimilar is pegfilgrastim, for the treatment of neutropenia.

The MAAs are listed as being up for an opinion at the CHMP’s latest monthly meeting, which is taking place from 14-17 September.

MenQuadfi?

Sanofi’s meningococcal group A, C, W135 and Y conjugate vaccine is likely to be MenQuadfi, approved in the US in April for the prevention of invasive meningococcal disease, including meningitis, caused by serogroups A, C, W and Y of Neisseria meningitidis.  (Also see "Keeping Track Of Approvals: US FDA Keeps Up Fast Pace In Oncology With Early Nods For Trodelvy, Pemazyre" - Pink Sheet, 26 Apr, 2020.) 

The other MAA from Sanofi that is up for an opinion relates to a recombinant quadrivalent flu vaccine – possibly the company's Flublok Quadrivalent for use in adults aged 18 and older  (Also see "Sanofi Forecasts Strong Flu Vaccine Growth, Accelerates COVID Plans" - Scrip, 29 Jul, 2020.) The company noted in a results presentation on 24 April this year that its Fluzone High Dose Quadrivalent – known as Efluelda QIV HD in Europe, excluding the UK and Ireland – had in April obtained "a positive end of procedure from the decentralized European procedure for active immunization in adults aged 65 and older for the prevention of influenza disease, allowing national licenses to be issued." 

Xarelto

Xarelto was approved in the EU in 2008 and it has also been available in other markets for a number of years.

Bayer told the Pink Sheet that "generic versions of Xarelto have already been approved in several countries of the EU" but that "in most of the European countries, compound patent protection for Xarelto continues until at least late 2023, including supplementary protection certificate, and... until then no approved version can be marketed without infringing Bayer’s patents." 

According to Bayer’s financials for the second quarter of 2020, sales of Xarelto were up again, largely as a result of higher volumes in China, Russia and Germany. (Also see "Bayer Q2 Pharma Sales Ravaged By COVID-19" - Scrip, 4 Aug, 2020.)

In the EU, Xarelto is approved for preventing atherothrombotic events after an acute coronary syndrome and for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation. It is also authorized for treating deep vein thrombosis and pulmonary embolism and for the prevention of venous thromboembolism in patients who are undergoing hip or knee replacement surgery. The indication sought for the rivaroxaban generic is “prevention of atherothrombotic events.”

Obiltoxaximab & Bupivacaine

SFL Regulatory Services filed the MAA for obiltoxaximab, which has EU orphan status, on behalf of Elusys Therapeutics, Inc.; the product was approved in the US under the brand name Anthim in 2016.

The sponsor of the bupivacaine MAA seems to be Pacira BioSciences, which announced recently that the US Food and Drug Administration had accepted the submission of its supplemental new drug application (sNDA) seeking expansion of its Exparel (bupivacaine liposome injectable suspension) label to include single-dose infiltration to provide postsurgical analgesia in children aged six and over. The expected action date by the FDA is 22 March 2021. Exparel was originally approved in 2012 for use in adults.

Oral explanations

The sponsors of three products at the later stages of the MAA review process were due, or possibly due, to provide an oral explanation during this month's CHMP meeting. Oral explanation meetings are held if the committee has any important last-minute questions that it wants the sponsor to address.

The products here are:

• Zogenix, Inc.’s fenfluramine, for the treatment of seizures associated with Dravet syndrome in children aged 2 years to 17 years and adults. This product was approved as Fintepla in the US in June.  (Also see "Zogenix Risks Fintepla Uptake With Dravet Drug’s High Price" - Scrip, 28 Jun, 2020.)

• Aimmune Therapeutics, Inc.'s arachis hypogaea allergens/arachis hypogaea allergens – an immunotherapy (OIT) for patients aged 4 to 17 years with a confirmed diagnosis of peanut allergy. Aimmune’s Palforzia [Peanut (Arachis hypogaea) Allergen Powder-dnfp was approved in the US in January. The company said that Palforzia was the first approved treatment for patients with peanut allergy.

• Agios Pharmaceuticals, Inc.'s ivosidenib for the treatment of adult patients (≥ 18 years old) with relapsed or refractory acute myeloid leukaemia with an isocitrate dehydrogenase-1 R132 mutation. Ivosidenib was approved in the US in May 2019 – in patients who are at least 75 years old or who have comorbidities that preclude the use of intensive induction chemotherapy.

Fenfluramine and ivosidenib have orphan status.

Meeting Highlights

The key outcomes of the CHMP meeting will be made public on 18 September. The committee’s opinions are sent to the European Commission, which has 67 days to take a legally binding decision valid throughout the EU. 

In CHMP meeting agendas, the EMA only identifies sponsors of MAAs where the product in question has orphan status. Other sponsors have been identified on the basis of company press releases, for example, or original research by the Pink Sheet.