August 05, 2020
Authorized medicines with new active substances in Switzerland in Q2 of 2020
Within the framework of the authorization procedure, the Swiss Agency for Therapeutic Products (Swissmedic) assesses the quality, safety, and effectiveness of the drugs based on the comprehensive scientific documentation submitted by the applicant.

If the criteria for authorization are fulfilled, Swissmedic grants the marketing authorization specifies the method of sale (on prescription only/dispensing point) and approves the information for healthcare professionals and the patient information.

In Q2 of 2020, Swissmedic authorized seven drugs:

In April 2020:

Zebinix®, tablets (eslicarbazepine acetate). Indication:

  • Monotherapy for the treatment of partial epilepsy with or without secondary generalization in adults with newly diagnosed epilepsy;
  • In combination with other drugs for adults, adolescents and children over six years for the treatment of partial epilepsy with or without secondary generalization
In May 2020:

Libtayo® concentrate for solution for infusion (cemiplimabum). Indication:

  • As monotherapy for the treatment of patients with metastatic cutaneous squamous cell carcinoma, or locally advanced cutaneous squamous cell carcinoma, who are not eligible for curative surgery or curative radiotherapy
TukysaTM, film-coated tablets (Tucatinibum). Indication:

  • In combination with trastuzumab and capecitabine indicated for the treatment of patients with metastatic HER2-positive breast cancer, who have previously received two or more anti-HER2 regimens in any setting, including trastuzumab, pertuzumab and trastuzumab emtansine (T-DM1)
Vitrakvi®, capsules (larotrectinibum). Indication for the treatment of adult and pediatric patients with solid tumors:

  • Who have a tumor with an NTRK (neurotrophic tyrosine receptor kinase) gene fusion without a known NTRK resistance mutation AND
  • Whose tumor is metastatic or where surgical resection is likely to result in severe morbidity AND
  • Who do not have satisfactory treatment options or who have progressed from previous treatment
  • Vitrakvi is not indicated for the treatment of lymphomas
Triogen, capsules (Trientini dihydrochloride). Indication:

  • For the treatment of copper storage disease (Wilson's disease) in patients who cannot tolerate treatment with D-Penicillamine
Quofenix®, tablets (Delafloxacinum). Indication:

  • Used to treat acute bacterial skin and skin structure infections (ABSSSI, Acute Bacterial Skin and Skin Structure Infections) in adults. Treatment with Quofenix is only indicated if the antibiotics recommended for the initial treatment of these infections are not considered suitable. The generally recognized guidelines for the appropriate use of antibacterial agents must be taken into account, in particular, recommendations for use to prevent the increase in antibiotic resistance
In June 2020:

Nubeqa® film-coated tablets (darolutamidum). Indication:

  • In combination with androgen deprivation therapy (ADT) for the treatment of adult patients with non-metastatic, castration-resistant prostate cancer (NM-CRPC), where there is a high risk of developing metastases
See all the details in English here.

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