Glaxo''s Relenza gets UK approval
21 Nov 2000
After having been refused approval on the grounds that the efficacy of the drug was not
proven, the new anti-flu drug from Glaxo, Relenza, has been finally approved by the
National Institute of Clinical Excellence (Nice) of the UK. Nice is the authority which
decides on which medicines should be funded by the National Health Service (NHS)
of the UK.
This approval would mean that more than 13.5 million patients of the NHS will be eligible to receive the anti-flu drug. In according this approval, Nice reversed an earlier decision and said high-risk patients including the elderly, asthmatics and diabetics would be eligible to receive the drug.
Nice had initially, in October last year, not approved the drug because it was not convinced of its efficacy. In addition to this were reports of adverse reactions amongst some patients, including breathing problems. Glaxo has since produced data from clinical trials that was unavailable when Relenza was first licensed.
The use of Relenza, which has been allowed for dispensation by nurses and pharmacists in the UK, will cost the NHS between 9.9 million and 15 million a year.
While the approval comes as good news for beleaguered Glaxo, which is seeing its merger with SmithKline Beecham proceed at a very slow pace, analysts believe that it would not make a significant contribution to sales as a flu treatment. This is because, according to analysts, demand for drugs like Relenza was relatively small with only an estimated 2 million people in Europe and US in the "at risk" category.
Glaxo management is, however, forecasting revenues of 200m in 2005, or about 1.5 per cent of Glaxos total sales, to come from Relenza.