Roche has received some good news about Viracept at last after European regulators recommended the lifting of a suspension that had stopped the firm from selling the HIV drug.
The European Medicines Agency’s Committee for Human Medicinal Products has recommended that the marketing authorisation on Viracept (nelfinavir) is re-instated following its suspension in August. Then, a temporary ban was placed on the drug following the discovery that some of the drug batches contained ethyl mesylate, a substance used in the production of Viracept which could cause cancer.
Now the CHMP says that it has assessed “the corrective and preventive measures” put in place by Roche, and these have also been verified by an inspection of the manufacturing site. As a result, the committee “has been reassured that the cause of the contamination has been eliminated” and that future production of Viracept would meet the required quality standards.
The next step is to wait for a final decision from the European Commission and Roche said it fully intends to re-supply Viracept once the suspension is lifted, though it may take a few months for the drug to be available again to prescribers and patients. William Burns, Roche’s head of pharmaceuticals, said that from the beginning, the firm “acted responsibly, quickly and always in the best interests of patients [as] the most prudent action was to recall the medication”.
So it should soon be back on the market in Europe but Viracept is facing problems elsewhere. Pfizer, which manufactures and markets the drug in North America (and in Japan), recently issued a warning saying that children in the USA who need to begin HIV treatment should not start regimens containing Viracept until further notice. The latter goes for pregnant women and, as a precautionary measure, those currently receiving Viracept should be switched to an alternative antiretroviral therapy for the timebeing, if possible.
Child-size Tamiflu backed in Europe
More good news for Roche came with the announcement that the European Commission has backed two lower-dose versions of its antiviral Tamiflu (oseltamivir) for children aged one and upwards.
The 30mg and 45mg capsules provide a convenient alternative to the previously-approved 75mg dose which was available in capsules and as a powder for oral suspension for use in children. Furthermore, Roche claimed, since the smaller capsules have a longer shelf life than the suspension formulation (five as opposed to two years), they also offer an improved option for government pandemic stockpiling. The lower-dose Tamiflu capsules were approved by the US Food and Drug Administration in July.