The Roche healthcare group in Basel has released new data which it says shows that its Tamiflu influenza drug is safe and effective for both children and the elderly.
The move follows recent questions about the drug.
Generically known as oseltamivir, Tamiflu is already used in the United States, Canada, Switzerland and Latin America. However, it is not approved for use by children aged 12 or under in the United States and Roche last week temporarily withdrew its bid for Europe-wide approval after regulators raised questions about the drug and requested more data.
The company, which has not issued details on what kind of questions were raised, said it would resubmit the bid later this year and was confident of approval. Analysts said the questions were likely related to at-risk groups like the elderly.
Roche said one large clinical trial involving nearly 700 children aged one to 12 showed a new liquid formulation of Tamiflu reduced the duration of the illness by 37 per cent and the severity of symptoms by 30 per cent.
It added that the drug allowed children to return to their normal activities two days earlier than those who received placebo, according to the company.
Another trial of 322 elderly people showed the drug reduced symptoms such as fever and chills by 36 per cent.
A third study focused on 140 elderly and at-risk adults that had previously been vaccinated and developed flu despite the vaccine. Again, the patients recovered two days earlier than those who took placebo.
All three studies were presented at a medical congress in Stockholm, Sweden.
swissinfo and agencies