Compassionate-use opinion for Tamiflu

Tamiflu

According to the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP), the first opinion on the compassionate use of a medicine has now been issued.

Compassionate-use programmes seek to give patients with a life-threatening, long-lasting or seriously disabling disease who have no available treatment options, access to treatments that are still under development and that have not yet been authorised.

The opinion, says reports, is based on a request from Finland and relates to an intravenous formulation of Roche's flu prevention and treatment product Tamiflu IV (oseltamivir).

No option

Reports on Pharma Times detail that, in its opinion, the CHMP states that compassionate-use Tamiflu IV should be considered only to treat critically-ill adults and children older than one year of age having a life-threatening condition due to suspected or confirmed pandemic (H1N1) infection or infection due to seasonal influenza A or B virus.

In addition, patients should also only receive compassionate-use if they fall under the following criteria:

• Patients are not responding to either oral or inhaled authorised antiviral medicinal products;
• Patients for whom drug delivery by a route other than IV (eg, oral oseltamivir or inhaled zanamivir) is not expected to be dependable or is not feasible.
  

However, the recommendation has come under fire because the CHMP has thus far been unable to qualify advice for infants below one year of age because of the absence of pharmacokinetic and safety data on the use of Tamiflu IV in this very young population. The organisation argues that if a physician decides to treat an infant aged less than one year, the decision should be taken based on the assessment of the benefit and risk for the individual. 

In addition, in alignment with the recommendation, the EMA has emphasized that these opinions are optional and complement national legislation - they do not replace it, nor do they create any legal framework within the EU member states.

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