Roche says that US regulators have approved its Tamiflu influenza treatment at two lower doses for children in a formulation with a longer shelf life that offers a better option for pandemic stockpiling.
The US Food and Drug Administration has approved the Swiss drugmaker’s supplemental New Drug Application to market Tamiflu (oseltamivir) capsules in 30mg and 45mg doses for the treatment and prevention of influenza types A and B in patients one year and older. The shelf life of the capsules is five years, which compares very favourably with the 24-month shelf life of the standard liquid suspension formulation.
“Roche continues to take steps to facilitate the use of antivirals in pandemic preparedness and response,” said Dominick Iacuzio, medical director at the Basel-based firm, adding that these lower dose capsules “not only provide governments with a new option for pandemic stockpiling, but also give prescribing physicians an alternative for patients who prefer a capsule formulation”.
Roche has received Tamiflu orders totalling 215 million treatment courses from more than 75 countries and has also donated 5.1 million treatment courses to the World Health Organisation to help contain any initial pandemic outbreak. The firm added that the 30 mg and 45 mg capsules will be available in the USA and for government stockpiling in time for the 2007-2008 flu season.
Warning over Avastin link to TE fistula
Meantime Roche’s partner Genentech has warned healthcare professionals that the firms’ blockbuster Avastin (bevacizumab) caused at least one fatality in a recent clinical study in patients with limited-stage small cell lung cancer. The study was carried out on 29 patients and combined chemotherapy and radiation plus Avastin.
According to the FDA, Genentech intends to revise the Avastin package insert to include more detailed information about possible adverse effects. The agency added there were two confirmed serious adverse events of respiratory disease tracheoesophageal fistula, one fatal, and a second death of unknown cause following an upper aerodigestive tract haemorrhage, in which TE fistula was suspected.
Six other cases of TE fistula have also been reported in other lung and oesophageal cancer studies using Avastin and chemotherapy alone or with concurrent radiation treatment, the FDA added, noting that Avastin is not approved for the treatment of small cell lung cancer, although the current prescribing information includes a description of gastrointestinal tract fistula formation in patients with colorectal cancer treated with Avastin.
