EMA recommends seven medicines for approval after September meeting

The European Medicines Agency’s (EMA) human medicines committee (CHMP) has recommended seven medicines for approval at its September 2020 meeting.

The CHMP adopted a positive opinion for Exparel (bupivacaine), for the treatment of post-operative pain. 

It also recommended granting marketing authorisations for two vaccines: MenQuadfi (meningococcal group A, C, W and Y conjugate vaccine), for prophylaxis against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W and Y; and Supemtek (Quadrivalent Influenza Vaccine (recombinant, prepared in cell culture)), for prophylaxis against influenza.

The CHMP recommended granting a marketing authorisation under exceptional circumstances for Obiltoxaximab SFL* (obiltoxaximab), for the treatment or post-exposure prophylaxis of inhalational anthrax.

The biosimilar medicine Nyvepria (pegfilgrastim) also received a positive opinion for reducing the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy.

The CHMP recommended a marketing authorisation be granted for the generic medicine Rivaroxaban Accord (rivaroxaban), an anticoagulant intended for the treatment and prevention of venous thromboembolism, pulmonary embolism and the prevention of atherothrombotic events in adults with various risk factors for such events.

The committee supported granting a marketing authorisation for Phelinun (melphalan), a hybrid medicine for the treatment of certain haematological and other cancers and as reduced intensity conditioning treatment prior to allogeneic haematopoietic stem cell transplantation in haematological diseases in adults and children. 

Other decisions from the CHMP include the agreement to re-examine the opinions and issue final recommendations for Elzonris (tagraxofusp) and Gamifant (emapalumab), following the committee’s negative opinions for these medicines adopted at the July 2020 meeting. 

The committee suggested granting an extension of indication to Olumiant (baricitinib) to include the treatment of moderate to severe atopic dermatitis in adult patients who are candidates for systemic therapy. It also recommended granting an extension of indication to Orfadin (nitisinone) to include the treatment of alkaptonuria, a rare metabolic disorder, in adult patients.

The committee recommended granting an extension of indication for Velphoro (mixture of polynuclear iron(III)-oxyhydroxide, sucrose and starches) to include control of serum phosphorus levels in children aged two or older with chronic kidney disease (CDK) stages 4-5 or with CDK on dialysis. 

Other extensions of indication recommended by the committee were for Deltyba, Flucelvax Tetra, Fycompa, Lynparza, Opdivo, Symkevi, Tecentriq, Yervoy, Zavicefta, Zejula and two extensions of indication for Kalydeco.

The CHMP completed its review of results from the RECOVERY study arm that involved the use of the corticosteroid medicine dexamethasone in the treatment of patients with COVID-19 admitted to hospital and has concluded that dexamethasone can be considered a treatment option for patients who require oxygen therapy (from supplemental oxygen to mechanical ventilation).

Negative opinions

The CHMP confirmed its recommendation to suspend all ranitidine medicines in the EU due to the presence of low levels of an impurity called N-nitrosodimethylamine (NDMA). This follows a re-examination of CHMP’s April 2020 opinion, which was requested by one of the companies marketing ranitidine medicines. NDMA is classified as a probable human carcinogen based on animal studies.