EMA speeds up Boehringer review
pharmafile | November 28, 2013 | News story | Sales and Marketing | Boehringer, faldaprevir, hepc
Boehringer Ingelheim’s hepatitis C candidate faldaprevir has moved a potential step closer to market with the news that the European regulator has granted it an accelerated assessment.
The German manufacturer is seeking a licence for faldaprevir in combination with pegylated interferon and ribavirin (PegIFN/RBV) for patients with genotype-1 (GT-1) hepatitis C virus (HCV).
The attraction for the authorities is that the drug is also been mooted as a treatment for difficult-to-cure populations such as those with HIV co-infection or advanced liver disease.
Although it is by no means sure that a speedy review by the EMA will lead to a recommendation from the CHMP – let alone marketing authorisation itself – Boehringer is confident that it could be available in Europe in the second half of 2014.
“Faldaprevir has been studied with PegIFN/RBV in a broad range of more than 3,300 patients typical of those that doctors see in every day clinical practice,” said Klaus Dugi, the company’s corporate senior vice president medicine.
In the Phase III STARTVerso 1 and 2 trials, the drug has been effective and safe “while also offering the convenience of once-daily dosing and no food restrictions,” he went on.
Data presented to the Association for the Study of Liver Diseases (AASLD) suggested the majority of treatment-naïve patients benefited from shorter regimes while being successfully treated.
Most receiving faldaprevir 120mg or 240mg added to PegIFN/RBV achieved viral cure compared with 62% (29 out of 47) who received placebo plus PegIFN/RBV.
Primary endpoint – viral cure 12 weeks after treatment finished – was achieved with every patient in Taiwan, 86% of those in Korea and 85% of patients in Japan in the faldaprevir arm.
The trials suggest other benefits for patients, too, with the vast majority – 95% taking the 120mg dose and 93% on 240mg – able to shorten their treatment to 24 weeks because their virus levels were low at week 4 and week 8.
Of these, 91% (120mg) and 92% (240mg) achieved viral cure and both doses were shown to be well-tolerated.
Wider figures from STARTVerso 1, presented in April, showed that up to 80% of patients from Europe and Japan treated with faldaprevir+ and PegIFN/RBV achieved viral cure compared with 52% in the placebo arm.
Data from STARTVerso 2 (which includes patients from the US and Canada as well as Taiwan and Korea) plus STARTVerso 3 and 4 (looking at treatment-experienced patients as well as those who have both HIV and HCV) are expected in 2014.
The fact that it achieved high response rates in patients with GT-1 HCV in Asia who have not been treated before is important because it is a geographical area where HCV is prevalent.
The World Health Organisation estimates there are 184 million people infected with HCV worldwide, with the disease causing half a million deaths each year, the majority of them in developing countries.
This month Gilead has run into patent trouble in India with its own HCV candidate sofosbuvir as campaigners supported by Médecins Sans Frontières filed a ‘patent opposition’ at the country’s Patent Office.
They believe Gilead’s drug, which would be marketed as Sovaldi, does not warrant a patent because it is ‘old science, existing compound’.
The campaigners’ aim is to make it possible for other manufacturers to produce their own version, thus slashing the drug’s anticipated price tag of $80,000 per course of treatment.
European regulators are set to approve sofosbuvir after the CHMP gave it the green light last week while a key FDA panel has already given its own verdict on the drug by recommending it for US use.
Adam Hill
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