Switzerland’s Roche has filed for European approval of a new indication of its influenza pill, Tamiflu (oseltamvir), in the prevention of flu in children aged one to 12 years.
Tamiflu is already approved for the treatment of influenza in adults and children aged over one year and for the prevention of influenza in adults and adolescents 13 years and older. Approval in this new indication would make Tamiflu available to prevent flu in very young children who are particularly vulnerable during an outbreak of the disease, and Roche says it is optimistic that the continent’s advisory body, the CHMP, will complete its review of the application before the end of the year. A filing for the same indication was filed with the US regulators in April this year.
It is estimated that children are three times more likely to be affected by flu – on average, one in 10 adults is affected by influenza annually, compared with one in three children.
- Meanwhile, Roche has been reprimanded by the US Food and Drug Administration following “false and misleading statements” made by a company sales representative about the company’s HIV medicine, Fuzeon (enfuvirtide), at a conference last November. In a warning letter dated last Friday, the agency said that the statements misbrand Fuzeon by recommending or suggesting uses for Fuzeon that are not actually approved by the FDA.
The representative apparently stated that Fuzeon is appropriate for all treatment-experienced patients, but failed to disclose that the product is appropriate only for and has been studied only in patients who are already being treated with other antiretroviral drugs who have evidence of HIV replication despite this treatment. Similarly, the FDA said that the representative also claimed that Fuzeon confers “100% antiviral activity,” thereby
suggesting that all patients will respond to the drug, and it would be appropriate for a broader range of patients than those for whom it is actually approved.
The firm has until July 29 to respond in writing to the warning letter.
