PARIS, Dec 26 (APM) - France's Official Journal (JO) on Friday published the addition of AbbVie's oral hepatitis C (HCV) multi-therapy as part of its group temporary authorisation (ATU de cohorte) to the list of products hospital pharmacists can dispense to out-patients.
The treatment comprises Exviera (dasabuvir 250 mg) and Viekirax (ombitasvir 12.5 mg+paritaprevir 75 mg boosted with ritonavir 50 mg) both in tablet form.
These antivirals are part of a new generation of HCV direct-acting antivirals (DAAs) that are more effective than the standard therapies and give rise to fewer adverse events, particularly in view of the absence of pegylated interferon in the treatment regimen.
The national agency for medicinal product safety, ANSM, does not mention this temporary authorisation on its website, nor does it mention the indication concerned. On Friday morning, no-one was available to answer phone calls either at ANSM or at AbbVie France.
In September, MP Gérard Bapt (Socialist party, Haute-Garonne) called on ANSM to grant an ATU to Exviera and Viekirax, mainly owing to the high price charged by Gilead for Sovaldi (sofosbuvir) the first DAA to arrive on the French market (APMMA 39790).
Questioned by APM, AbbVie's French subsidiary said at the end of November it had requested an ATU “in all the indications for which we hold robust data”.
It added then it hoped to launch its product in France early in January 2015 within the framework of the ATU and that it wanted the product to remain free of charge until such time as its packaging is changed, due to occur within three months of European marketing approval.
In November, the multi-therapy was given a positive opinion by the CHMP for HCV with or without ribavirin for genotypes 1 and 4.
It was approved in the U.S. on Monday for genotype 1 patients. AbbVie plans to market it at a price considerably lower than that of its competitor product Gilead’s Harvoni (sofosbuvir+ledipasvir) (APMMA 40889).
(Order of December 24, Journal officiel of December 26, text 101)
gb/aki/nh
TRY APM Market Access AND GET ACCESS TO THE FULL CONTENT
Interviews with KOLs/senior executives amongst the Regulators, Payers, Health, Medical & Pharmaceutical organisations
Events coverage with a unique focus on Market Access & sustainability of healthcare systems
6 European bureaus : Berlin, Brussels, London, Madrid, Milan & Paris
Ask for a Free trial and get access to the latest stories
Our coverage includes:
- Health Care
- Market Access
- HTA – policies & practices
- European medicine regulations
- Drug safety issues
- Pricing & Reimbursement
- International medicines agencies
If you are a Payer, Pharmaceutical or Consulting professional our premium data will keep you informed on the regulatory, pricing, market access and cost-effectiveness issues that impact all stakeholders.
REQUEST
an initial 10 day temporary access of APM Market Access.
