HCPW P/ PCW P m eeting: feedback from CHMP Presented by Concha - - PowerPoint PPT Presentation

▶

Jan 17, 2024 351 likes •516 views

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.

SLIDE 1

An agency of the European Union

HCPW P/ PCW P m eeting: feedback from CHMP

Presented by Concha Prieto (CHMP)

20 September 2017

SLIDE 2

HCPWP/ PCWP feedback from CHMP – September 2017 1

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).

SLIDE 3

HCPWP/ PCWP feedback from CHMP – September 2017 2

Positive opinions on new m edicines June – Sept 2 0 1 7 Cancer: 9

Name Active S Indication Fotivda tivozanib Renal cell carcinoma Kisqali ribociclib Breast cancer Xerm elo telotristat ethyl Carcinoid syndrome

Orphan Restricted prescription

Authorised

EC EC decision pending

monitored (supervision) HCP

EC EC EC

SLIDE 4

HCPWP/ PCWP feedback from CHMP – September 2017 3

Name Active S Indication

Bavencio

avelumab Metastatic Merkel cell carcinoma

Lutathera

lutetium ( 177lu)

xodotreotide

Gastroenteropancreatic neuroendocrine tumours

Rydapt

midostaurin Acute myeloid leukaemia, systemic mastocytosis.

Tecentriq

atezolizumab Urothelial carcinoma and of non-small cell lung cancer

Zejula niraparib Ovarian cancer Tookad padeliporfin Adenocarcinoma of prostate

Positive opinions on new m edicines June – Sept 2 0 1 7 Cancer: 9

EC EC EC EC EC EC

SLIDE 5

HCPWP/ PCWP feedback from CHMP – September 2017 4

Name Active S Indication Maviret glecaprevir / pibrentasvir

Chronic hepatitis C virus infection

Vosevi sofosbuvir / velpatasvir / voxilaprevir

Chronic hepatitis C virus infection

Sym tuza darunavir / cobicistat / emtricitabine / tenofovir alafenamide

HIV infection

Positive opinions on new m edicines June – Sept 2 0 1 7

I nfectious diseases; 3

EC EC

SLIDE 6

HCPWP/ PCWP feedback from CHMP – September 2017 5

Central Nervous System : 3

Name Active S Indication

Mavenclad

cladribine Multiple sclerosis Nyxoid naloxone Opioid overdose Zubsolv buprenorphine/ naloxone Opiod dependence

Positive opinions on new m edicines June – Sept 2 0 1 7

EC EC EC

SLIDE 7

HCPWP/ PCWP feedback from CHMP – September 2017 6

Positive opinions on new m edicines June – Sept 2 0 1 7

Name Active S Indication Verkazia Cyclosporin

Severe vernal keratoconjunctivitis in children and teenagers

EC Ophtalm ology Blood products

Name Active S Indication VeraSeal human fibrinogen / human thrombin Sealant during surgery

SLIDE 8

HCPWP/ PCWP feedback from CHMP – September 2017 7

Positive opinions on new m edicines June – Sept 2 0 1 7

Name Active S Indication Elebrato Ellipta Trelegy Ellipta fluticasone/ umeclidinium/ vilanterol COPD

EC Respiratory system Derm atology

Name Active S Indication Dupixent dupilumab Severe atopic dermatitis

SLIDE 9

HCPWP/ PCWP feedback from CHMP – September 2017 8

Cancer

Name Active S Indication Onzeald etirinotecan pegol

Advanced breast cancer whit brain metastasis

Adlum iz anamorelin hydrochloride

Anorexia, cachexia in patients with non-small cell lung cancer.

Hum an I GG1 m onoclonal antobody for hum an I L-1 alpha

Debilitating symptoms of advanced colorectal cancer

Masipro masitinib

Systemic mastocitosis

Negative opinions on new m edicines June – Sept 2 0 1 7

SLIDE 10

HCPWP/ PCWP feedback from CHMP – September 2017 9

Central Nervous System

Name Active S Indication Fanaptum iloperidone Treatment of schizophrenia

Negative opinions on new m edicines June – Sept 2 0 1 7

SLIDE 11

HCPWP/ PCWP feedback from CHMP – September 2017 10

Final advices adopted

Scientific Advices ( June - Septem ber 2 0 1 7 )

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

SLIDE 12

HCPWP/ PCWP feedback from CHMP – September 2017 11

PRI ME eligibility – June – Sept 2 0 1 7

Name Substance type Therapeutic area Therapeutic indication Date

2 -hydroxy-6 -( ( 2 - ( 1 -isopropyl-1 H- pyrazol-5 - yl) pyridin-3 -yl) m ethoxy) benzald ehyde ( GBT4 4 0 ) Polatuzum ab vedotin Vocim agene am iretrorepvec

Chemical Biological Advanced Therapy Haematology Oncology Oncology Treatment of Sickle Cell Disease Treatment of relapsed and refractory patients with diffuse large B cell lymphoma Treatment of high grade glioma

June-2017 June-2017 July-2017

SLIDE 13

HCPWP/ PCWP feedback from CHMP – September 2017 12

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 Adlum iz Anamorelin hydrochloride Oncology Masipro Masitinib Oncology

SLIDE 14

HCPWP/ PCWP feedback from CHMP – September 2017 13

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

SLIDE 15

HCPWP/ PCWP feedback from CHMP – September 2017 14

Thank you!

cpieto@aem ps.es