Neoral Backed For Severe Arthritis By FDA Panel

10 February 1997

Novartis' microemulsion formulation of its best-sellingimmunosuppressant drug ciclosporin, Neoral, has been recommended for approval by a US Food and Drug Administration panel, both alone and in combination with methotrexate, for the treatment of patients with severe active rheumatoid arthritis.

In the USA, Neoral is currently approved for the prevention of transplant rejection in kidney, liver and heart transplants. The USA is lagging behind somewhat in approving indications for the drug, as in certain other countries, such as the UK, ciclosporin is indicated for a broader range of uses including severe cases of rheumatoid arthritis, psoriasis and atopic dermatitis.

Novartis presented data at the advisory meeting which showed that Neoral could confer a statistically significant clinical benefit in rheumatoid arthritis patients, and also showed that Neoral plus methotrexate was effective in patients who had an inadequate response to methotrexate alone.

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