Manufacturing issues are to blame again for another delayed 2016 approval as Roche announces its speedy FDA review was for nought as it must now wait another 3 months for a green light.
In a brief update the Swiss major said the PDUFA date for Ocrevus (ocrelizumab), which had been December 28, will now not be met after the agency demanded “additional data by Roche regarding the commercial manufacturing process of Ocrevus.”
The new PDUFA date is three months down the line, while the FDA sifts through the new info, and is set for March 28, 2017. The Big Pharma stressed the regulator had no concerns over the safety or efficacy of its med.
Back in the summer, it looked as if Roche was on a smooth course to a pre-New Year approval after gaining the FDA priority review tag, which speeds up its internal process. The med is seeking a license for both relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS).
“We strongly believe in the potential of Ocrevus as a new therapeutic option for both people with relapsing forms of multiple sclerosis and primary progressive multiple sclerosis,” said Sandra Horning, CMO and head of global product development at Roche.
“We are working closely with the FDA during their review and committed to bringing this innovative medicine to the over 400,000 people with MS in the US living with this disabling disease as quickly as possible.”
RMS already has a number of treatments on the market from Novartis, Biogen, German Merck, Sanofi, Teva and others, but there are currently no drugs on the market for the progressive form of the disease, which makes up around 10-15% of all MS patients.
The drug, administered by intravenous infusion every six months, showed in clinical trials that it could better Merck's older injectable treatment Rebif in patients suffering from RMS. When compared with placebo, the drug also reduced the risk of disability progression by 24% in patients with the particularly debilitating PPMS.
The drug is also on track for a European approval for the middle of next year, although it is not clear whether the manufacturing issues will affect its EU review.
Sales for the treatment, which would for the first time be able to cover 95% of all MS sufferers, are expected to hit anywhere from $3 billion to as much as $7 billion at peak, depending on the optimism of the analyst you speak to.
Roche will need it to, as the company will soon start to face the threat of biosimilars to its aging blockbuster cancer drugs.
A number of Big Pharmas, including most notably AstraZeneca and its ZS-9, have been hit with major delays over manufacturing issues for their meds, a situation that has contributed to 2016 seeing a much lower level of approvals when compared to the past two years.
Ocrevus’ delay will now also lower that level further, given that it was due to be approved before 2017.