Russian company considers production of generic version of Trikafta

15 November 2023

The Russian Medical Research Company, which is a subsidiary of Swiss firm Genfa Global, is considering the production of Trilexa, which is a generic of Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor), a drug for treatment of cystic fibrosis from the USA’s Vertex Pharmaceuticals (Nasdaq: VRTX), The Pharma Letter’s local correspond reports.

Planned production volumes are not disclosed, while the final decision will be taken after the assessment of the potential demand for the drug in the Russian market.

The original Trikafta appeared in the market in 2019 when it was approved by the US Food and Drug Administration (FDA). In Russia, this drug was registered only in August 2023, although the company submitted an application back in 2021. Local patients have repeatedly asked the Russian Ministry of Health to speed up this process: if the drug is not registered in Russia, it could only be obtained by decision of a council of doctors, and this significantly increases the waiting time.

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