PARIS, Jan 6 (APM) - France’s drugs regulator ANSM has announced two new temporary authorisations (ATU) for AbbVie’s hepatitis C (HCV) multi-therapy and for Bristol-Myers Squibb’s melanoma treatment Opdivo (nivolumab).
The AbbVie multi-therapy ATU is divided into two parts corresponding to the two drugs that make up the therapy: first, the ombitasvir 12.5 mg+paritaprevir 75 mg+ritonavir 50 mg combination in a tablet is to be taken once a day, and second, dasabuvir 250 mg, in a tablet is to be taken twice a day.
Posted on its website last week, ANSM said the triple therapy has two indications:
:: in combination with the dasabuvir with or without ribavirin in the treatment of chronic hepatitis C caused by HCV genotype 1 in adult patients with advanced stage disease (liver fibrosis stage F3 or compensated cirrhosis or presenting extrahepatic HCV manifestations)
:: with ribavirin in the treatment of chronic hepatitis C caused by HCV genotype 4 in adult patients with advanced stage disease (with liver fibrosis stage F3 or compensated cirrhosis or presenting extrahepatic HCV manifestations).
The dasabuvir ATU only provides for a combination with the ombitasvir+paritaprevir+ritonavir triple therapy, with or without ribavirin.
The European Medicines Agency’s (EMA) scientific committee (CHMP) recommended the multi-therapy in its November meeting in the treatment of chronic HCV genotypes 1 and 4 in adults (APMMA 40540). The brand names of the two drugs are Viekirax for the triple therapy and Exviera for the dasabuvir.
The Official Journal (JO) of December 26 published the addition of the multi-therapy to the list of products hospital pharmacists can dispense to out-patients under its group temporary authorisation (ATU de cohorte), though without specifying the scope (APMMA 40942).
The treatment was approved in the U.S. on December 19, under the name Viekira Pak (APMMA 40889).
Concerning nivolumab, the group temporary authorisation indication, that began on Monday, is the treatment of adult patients with unresectable melanoma (stage III) or metastatic (stage IV) that no longer responds to BMS’ Yervoy (ipilimumab) for patients without the BRAFV600 mutation or that no longer responds to ipilimumab and a BRAF inhibitor, in the case of patients with a BRAFV600 mutation.
Patients should have an ECOG performance status of 0 or 1, and adequate organ functions defined by haematological and biochemical criteria. Given the response lead time and adverse events, the treatment is reserved for patients with a life expectancy greater than three months.
At the end of September, BMS announced that the EMA had the filing for Opdivo (nivolumab) under an accelerated review procedure. The product has been approved in the U.S. since December 22 (APMMA 40908).
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