HCPW P/ PCW P m eeting: feedback from CHMP Presented by Concha Prieto (CHMP) 20 September 2017 An agency of the European Union
Sum m ary • CHMP opinions (June-September) – New medicines. – Scientific Advices/ Protocol Assistance. – PRIME eligibility. • HCP and patients input provided in the context of CHMP activities (June-September). 1 HCPWP/ PCWP feedback from CHMP – September 2017
Positive opinions on new m edicines June – Sept 2 0 1 7 Cancer: 9 Name Active S Indication EC Fotivda tivozanib Renal cell carcinoma EC Kisqali ribociclib Breast cancer Xerm elo telotristat ethyl Carcinoid syndrome EC EC EC EC decision pending monitored (supervision) HCP Authorised Orphan Restricted prescription 2 HCPWP/ PCWP feedback from CHMP – September 2017
Positive opinions on new m edicines June – Sept 2 0 1 7 Cancer: 9 Name Active S Indication Metastatic Merkel cell carcinoma EC Bavencio avelumab EC lutetium ( 177 lu) Gastroenteropancreatic neuroendocrine Lutathera oxodotreotide tumours EC Acute myeloid leukaemia, systemic Rydapt midostaurin mastocytosis. EC Urothelial carcinoma and of non-small Tecentriq atezolizumab cell lung cancer EC Zejula niraparib Ovarian cancer Tookad padeliporfin Adenocarcinoma of prostate EC 3 HCPWP/ PCWP feedback from CHMP – September 2017
Positive opinions on new m edicines June – Sept 2 0 1 7 I nfectious diseases; 3 Name Active S Indication EC Maviret glecaprevir / pibrentasvir Chronic hepatitis C virus infection sofosbuvir / velpatasvir / EC Vosevi Chronic hepatitis C virus infection voxilaprevir darunavir / cobicistat / Sym tuza emtricitabine / tenofovir HIV infection EC alafenamide 4 HCPWP/ PCWP feedback from CHMP – September 2017
Positive opinions on new m edicines June – Sept 2 0 1 7 Central Nervous System : 3 Name Active S Indication EC Mavenclad cladribine Multiple sclerosis EC Nyxoid naloxone Opioid overdose buprenorphine/ Zubsolv Opiod dependence EC naloxone 5 HCPWP/ PCWP feedback from CHMP – September 2017
Positive opinions on new m edicines June – Sept 2 0 1 7 Ophtalm ology Name Active S Indication EC Severe vernal keratoconjunctivitis in children Verkazia Cyclosporin and teenagers Blood products Name Active S Indication human fibrinogen / VeraSea l Sealant during surgery EC human thrombin 6 HCPWP/ PCWP feedback from CHMP – September 2017
Positive opinions on new m edicines June – Sept 2 0 1 7 Respiratory system Name Active S Indication Elebrato Ellipta fluticasone/ umeclidinium/ EC COPD Trelegy Ellipta vilanterol Derm atology Name Active S Indication EC Dupixent dupilumab Severe atopic dermatitis 7 HCPWP/ PCWP feedback from CHMP – September 2017
Negative opinions on new m edicines June – Sept 2 0 1 7 Cancer Name Active S Indication Onzeald etirinotecan pegol Advanced breast cancer whit brain metastasis Anorexia, cachexia in patients with non-small cell lung Adlum iz anamorelin hydrochloride cancer. Hum an I GG1 m onoclonal antobody for Debilitating symptoms of advanced colorectal cancer hum an I L-1 alpha Masipro masitinib Systemic mastocitosis 8 HCPWP/ PCWP feedback from CHMP – September 2017
Negative opinions on new m edicines June – Sept 2 0 1 7 Central Nervous System Name Active S Indication Fanaptum iloperidone Treatment of schizophrenia 9 HCPWP/ PCWP feedback from CHMP – September 2017
Scientific Advices ( June - Septem ber 2 0 1 7 ) Final advices adopted June July Sept Scientific Advices 30 19 39 Follow up SA 14 9 3 Protocol Assistance 8 8 6 Follow up PA 4 7 8 Qualification Advices 1 3 1 HTA 2 5 2 Total 5 9 5 1 5 9 10 HCPWP/ PCWP feedback from CHMP – September 2017
PRI ME eligibility – June – Sept 2 0 1 7 Name Substance Therapeutic area Therapeutic indication Date type 2 -hydroxy-6 -( ( 2 - June-2017 Chemical Haematology Treatment of Sickle Cell ( 1 -isopropyl-1 H- Disease pyrazol-5 - yl) pyridin-3 -yl) m ethoxy) benzald ehyde ( GBT4 4 0 ) Polatuzum ab June-2017 Biological Oncology Treatment of relapsed and vedotin refractory patients with diffuse large B cell lymphoma July-2017 Vocim agene Advanced Oncology Treatment of high grade am iretrorepvec Therapy glioma 11 HCPWP/ PCWP feedback from CHMP – September 2017
I nteraction betw een CHMP and HCP: Participation in SAG and Ad-Hoc Experts Groups Contributing for decision on recom endations Name Active S Therapeutic area Mavenclad Cladribine CNS Ocrevus Ocrelizumab CNS Gadolinium Radiopharmaceutical Onzeal Etirinotecan pegol Oncology Factor VI I I Hematology Anamorelin Adlum iz Oncology hydrochloride Masipro Masitinib Oncology 12 HCPWP/ PCWP feedback from CHMP – September 2017
I nteraction betw een CHMP and patients: Participation of patients in CHMP m eetings Contributing for decision on recom endations Name Active S Therapeutic area Raxone Idebenone Duchenne 13 HCPWP/ PCWP feedback from CHMP – September 2017
Thank you! cpieto@aem ps.es 14 HCPWP/ PCWP feedback from CHMP – September 2017
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