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.
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
Login to your accountTry before you buy
7 day trial access
Become a subscriber
Or £77 per month
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed
Chairman, Sanofi Aventis UK
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze