The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended six new medicines, including one advanced therapy medicinal product (ATMP), for approval at its June meeting.
The CHMP recommended granting a conditional marketing authorisation for the ATMP Zalmoxis as an adjunctive, or add-on, treatment for adult patients receiving a haploidentical haematopoietic stem cell transplant (HSCT) for types of blood cancer to aid immune reconstitution and reduce the risk of graft-versus-host disease. Zalmoxis has an orphan designation. For more information, please see the press release in the grid below.
The Committee also recommended granting a marketing authorisation for Cinqaero (reslizumab) as an add-on treatment for adult patients with severe eosinophilic asthma.
The generic medicine Atazanavir Mylan (atazanavir) was recommended by the CHMP for the treatment of human immunodeficiency virus-1 (HIV-1) infections.
Three hybrid applications received positive recommendations from the Committee. Aerivio Spiromax and Airexar Spiromax, both containing salmeterol xinafoate and fluticasone propionate, were recommendedfor the treatment of asthma and chronic obstructive pulmonary disorder (COPD). Nordimet (methotrexate) was recommended for the treatment of active rheumatoid arthritis, juvenile idiopathic arthritis and severe psoriatic arthritis. Hybrid applications rely in part on the results of pre-clinical tests and clinical trials for a reference product and in part on new data.
Request for re-examination of CHMP recommendation
The applicant for Ninlaro has requested a re-examination of the CHMP’s negative opinion for this medicine adopted at the May 2016 meeting. Upon receipt of the grounds for re-examination, the CHMP will re-examine this opinion and issue a final opinion.
Seven recommendations on extensions of therapeutic indications
The Committee recommended extensions of indications for Cervarix, Ilaris,Keytruda, Nevanac, RoActemra, Ryzodeg and Zontivity.
Negative opinion on extension of indication
The CHMP adopted a negative opinion on the request for an extension of therapeutic indication for Arzerra. A questions and answers document is available in the grid below.
Start of review: Pharmaceutics International Inc
The CHMP started a review of medicines manufactured by Pharmaceutics International Inc, USA. This follows an inspection in February 2016 which highlighted several shortcomings in relation to good manufacturing practice (GMP). For more information, please see the start of referral document in the grid below.
Outcome of Alkem Laboratories Ltd review
The CHMP recommended the suspension of a medicine (Riluzole Alkem), for which studies were conducted at the Alkem Laboratories Ltd site in Taloja, India, and has required companies to provide new data for another medicine before it can be authorised in the EU. The recommendations follow a joint routine inspection by German and Dutch authorities in March 2015. For more information, please see the public health communication in the grid below.
Review of a safety signal for Adempas
The Committee recommended that Adempas (riociguat) should not be used in patients with symptomatic pulmonary hypertension associated with idiopathic interstitial pneumonia or PH-IIP (high blood pressure in lung arteries caused by a lung disease called idiopathic interstitial pneumonia). These recommendations have been issued in the context of a review of a safety signal. For more information, please see the public health communication in the grid below.
Update to product information for Noxafil
The CHMP has warned that Noxafil (posaconazole) tablets and oral suspension have different doses and are not interchangeable. The product information for the medicine is to be updated to strengthen warnings that the two dose forms given by mouth cannot be simply interchanged at the same dose. For more information, please see the public health communication in the grid below.
Withdrawals of applications
Applications for marketing authorisations for Alendronic Acid/Colecalciferol Mylan (alendronic acid/colecalciferol), Arikayce (amikacin), Docetaxel Sun (docetaxel) andKyndrisa (drisapersen) have been withdrawn. Questions-and-answers documents on these withdrawals are available in the grid below.