Seven new medicines recommended for approval

EMA’s human medicines committee (CHMP) 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.

The Committee 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) received a positive opinion for reducing the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy.

The Committee recommended granting a marketing authorisation 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 CHMP recommended 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. Hybrid applications rely in part on the results of pre-clinical tests and clinical trials of an already authorised reference product and in part on new data.

Start of re-examination of recommendations for new medicines

The applicants for Elzonris (tagraxofusp) and Gamifant (emapalumab) have requested re-examination of the Committee’s negative opinions for these medicines adopted at the July 2020 meeting. The CHMP will now re-examine the opinions and issue final recommendations.

Fifteen recommendations on extensions of therapeutic indication

The Committee recommended 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. This is the first medicine for moderate as well as severe atopic dermatitis that patients can take orally.

The CHMP recommended granting an extension of indication to Orfadin (nitisinone) to include the treatment of alkaptonuria, a rare metabolic disorder, in adult patients. There are currently no approved medicines for alkaptonuria and treatment options are limited to dealing with the outcomes of the disease as they arise.

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 DeltybaFlucelvax TetraFycompaLynparzaOpdivoSymkeviTecentriqYervoy, ZaviceftaZejula and two extensions of indication for Kalydeco.

Outcome of review of dexamethasone for the treatment of COVID-19

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).

Outcome of re-examination of recommendation on ranitidine medicines

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 (a substance that could cause cancer) based on animal studies.

Posted on the EMA website on 18 September 2020