EMA with positive approval recommendations for 13 new drugs – including two anticancer drugs and three orphan drugs
About the author
Prof. Matthias P. Schönermark, M.D., Ph.D.
Founder and Managing Director
Founder and Managing Director
Fon: +49 511 64 68 14 – 0
Fax: +49 511 64 68 14 18
Fax: +49 511 64 68 14 18
The antibiotic Vabomere (Meropenem-Trihydrat/Vaborbactam from Rempex London), the migraine product Emgality (Galcanezumab from Lilly) and Dielstrigo (Doravirin/Lamivudin/Tenofovir-Disoproxil) as well as Pifeltro (Doravirin) from MSD for the treatment of HIV-1-infections received positive recommendation. The approved anticancer drugs are Apealea (Paclitaxel from Oasmia Pharmaceuticals) for the treatment of ovarian cancer and the monotherapy with Brigatinib (Alunbrig from Takeda) for the treatment of anaplastic lymphoma kinase (ALK) – positive advanced non-small cell lung cancer which has been previously treated with Crizotinib. Alunbrig is the fourth approved ALK-Inhibitor on EU-Level after Crizotinib, Ceritinib and Alectinib. With Lorlatinib from the pharmaceutical company Pfizer, another ALK inhibitor is currently amidst the european approval process.
Further positive approval recommendations were received for the biosimilars Fulphila (Pegfilgrastim from Mylan), Pelmeg (Pegfilgrastim from Cinfa Biotech) and Ziextenzo (Pegfilgrastim from Sandoz) for the treatment of neutropenia and the hybrid drug Buvidal (Buprenorphin from Camurus) for the treatment of opioid dependency.
The positive orphan drugs are Jivi (Damoctocog alfa pegol from Bayer) for the treatment of hemophilia A, Poteligeo (Mogamulizumab from Kyowa Kirin) for the treatment of mycosis fungoides or the Sézary syndrome and the gene therapy Luxturna (Voretigene neparvovec from Spark Therapeutics) in inherited retinal dystrophies caused by biallelid RPE65 mutations. Due to the high costs of the gene therapy with Luxturna, the reimbursement issue and the question of innovative payment models which will become established on European level for gene therapies will be of particular interest in the future.
SKC is the leading strategy consultancy in the Germen healthcare sector. For many years, we have been supporting pharmaceutical companies in providing medicines for rare diseases to German and European patients, in particular. As experts in the field of gene therapies, we are also in regular communication with relevant stakeholders.
Our corresponding white papers will give you more insight:
- White Paper: Successful Market Access for Gene Therapies - strategic challenges and best practice
- White Paper: Orphan Drugs in Germany – lessons learned from AMNOG, best and worst practices and strategic implications
BY Prof. Matthias P. Schönermark, M.D., Ph.D., managing director and Michèl Schikowski, M.Sc. Health Economics
Sources:
Apotheke adhoc: Grünes Licht für neue Krebsmittel (German only)
EMA - European Medicines Agency