Human medicinal products with a new active substance authorised in 2019

Authorisation procedure Approvals Rejections Withdrawals Total
NA NAS Standard 20 2 3 25
NA NAS FTP 2 0 0 2
NA NAS as per Art. 13 TPA 3 0 0 3
NA NAS PPN 4 0 0 4
Total 29 2 3 34
FTP: Fast-track authorisation procedure
TPA: Therapeutic Products Act
NA NAS: New application for a new active substance
PPN: Procedure with prior notification

In 2019, Swissmedic issued decisions authorising 34 human medicinal products with new active substances. In 18% of cases, a fast-track authorisation procedure was used (FTP/PPN), and in 9% of cases, Swissmedic based its decision upon the assessment of a foreign regulatory authority with comparable medicinal product control (Art. 13 TPA).

One in three of the newly authorised innovative medicinal products is used in cancer treatment; thus the trend of previous years was continued in 2019.

Product name     
Alimentary tract and metabolism

Nephropathic cystinosis

Blood and blood-forming organs
Cablivi Acquired thrombotic thrombocytopenic purpura (aTTP)
Jivi Haemophilia A
Esperoct Haemophilia A
Monofer Iron deficiency
Takhzyro Preventing attacks of hereditary angioedema
Dupixent Moderate to severe atopic dermatitis
Anti-infectives for systemic use
Zavicefta Infections
Pifeltro HIV infection
Biktarvy HIV infection
Vaxelis Primary and booster vaccination in infants and toddlers from the age of six weeks to four years (before the fifth birthday) against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by haemophilus influenzae type-b (Hib).
Antineoplastic and immunomodulating agents
Mylotarg Acute myeloid leukaemia
Mektovi Melanoma with BRAF V600 mutation
Braftovi Melanoma with BRAF V600 mutation
Vizimpro Advanced or metastatic non-small cell lung cancer (NSCLC)
Verzenios Locally advanced or metastatic HER2-negative breast cancer
Talzenna Locally advanced or metastatic HER2-negative breast cancer with a germline BRCA mutation
Erleada Non-metastatic, castration-resistant prostate cancer (NM-CRPC)
Skyrizi Moderate to severe plaque psoriasis
Ilumetri Moderate to severe plaque psoriasis
Yescarta Relapsed or refractory diffuse large B-cell lymphoma (DLBCL)
Primary mediastinal large B-cell lymphoma (PMBCL)  
Musculoskeletal system
Spherox Symptomatic articular cartilage defects in the femoral condyles and patella
Nervous system
Ajovy Preventive treatment of migraines
Emgality Preventive treatment of migraines
Fampyra Multiple sclerosis
Onpattro Hereditary transthyretin amyloidosis (hATTR amyloidosis)
Radicava Amyotrophic lateral sclerosis (ALS)
Respiratory system
Respirationstrakt Cystic fibrosis
Lutathera Metastatic or non-resectable, progressive, well-differentiated (G1 and G2) somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumours (GEP‑NETs)