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).
| 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 |
TPA: Therapeutic Products Act
NA NAS: New application for a new active substance
PPN: Procedure with prior notification
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 |
Indication |
|---|---|
| Alimentary tract and metabolism | |
| Procysbi | 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 |
| Dermatologicals | |
| 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 |
| Miscellaneous | |
| Lutathera | Metastatic or non-resectable, progressive, well-differentiated (G1 and G2) somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumours (GEP‑NETs) |