Roche has been boosted by the news that Europe’s regulator has found no new safety concerns linked to 19 of the Swiss major drugs following a pharmacovigilance inspection.
The European Medicines Agency began a review in 2012 after an inspection identified some safety data relating to these drugs that had not previously been provided by Roche. The therapies covered by the probe included many of its big-earning cancer drugs such as MabThera/Rituxan (rituximab), Herceptin (trastuzumab), Avastin (bevacizumab) and Tarceva (erlotinib), as well as RoActemra/Actemra (tocilizumab) for rheumatoid arthritis and Tamiflu (oseltamivir).
The probe followed an inspection in May 2012 by the UK Medicines and Healthcare products Regulatory Agency, “which identified serious shortcomings of Roche’s pharmacovigilance processes”. At the time, some 80,000 reports for medicines marketed by Roche in the USA collected through a company-sponsored patient support programme had not been assessed to determine whether they should be reported as suspected adverse reactions to European authorities. Roche notes that the figure came down to 23,000 unreported adverse events 13,000 of which were fatal.
Now, the investigartion by the agency’s Pharmacovigilance Risk Assessment Committee of the impact of the additional data provided by Roche on the drugs concerned “has not identified any important new safety concerns”. The EMA adds that “the balance of benefits and risks of these medicines has not been affected and there is no new advice regarding their use”.
However, as Roche “continues to provide additional data as part of their obligatory follow-up, they are required to ensure that these data are included and considered in their routine pharmacovigilance activities”, the EMA concludes.
Furthermore, the Basel-headquartered group may still face hefty fines for failing to comply with drug safety reporting standards under a separate investigation that began in October 2012. If found guilty, Roche could be fined up to 5% of its sales in the European Union.
UPDATE: Meantime, this morning, the European Commission has approved Roche’s Kadcyla for advanced HER2-positive breast cancer.
The antibody drug conjugate, approved in the USA in February, combines the Swiss major’s blockbuster Herceptin (trastuzumab) with partner ImmunoGen’s chemotherapy DM1 (emtansine). It will be available for patients who were previously treated with Herceptin and taxanes.
Roche chief medical officer Hal Barron said the latest approval “is important because this type of targeted medicine has been shown in clinical studies to offer clear benefits for people with advanced HER2-positive breast cancer”. He added that now Kadcyla has the green light, “we can begin discussions with the relevant EU reimbursement authorities to ensure that people who need this medicine can receive it as quickly as possible.”
