The hopes of multiple sclerosis patients that a drug, which showed promise in treating their condition might be returned to the market soon after its withdrawal a month ago, were dashed yesterday. It emerged a third patient who used it had developed serious side-effects.
The latest case is significant as the patient using the drug Tysabri was not using it in combination with another drug.
Tysabri was withdrawn at the end of February when it emerged two MS patients using it in combination with another drug, Avonex, developed Progressive Multifocal Leucoencephalopathy (PML), a rare infection of the central nervous system which can be fatal.
The Elan-produced drug was also being used to treat Crohn's disease, a bowel disorder, and rheumatoid arthritis and this latest case of PML was in a patient being treated for Crohn's disease. The patient is now dead, as is one of the two other patients known to have developed PML while taking the drug.
MS Ireland said the latest news was disappointing for multiple sclerosis patients.
Its chief executive Graham Love said: "We had been hoping the development of PML was in response to the 'combination effect' of taking two MS drugs (Tysabri and Avonex) and that Tysabri as a immunotherapy would be proven safe and therefore return to the market.
"This latest case of PML however appears to have been observed in a patient taking Tysabri on its own."
He added that Tysabri had initially offered great hope to those living with MS. The Food and Drug Administration (FDA) in the US had fast-tracked Tysabri's licence, granting it last November in response to a reported 66 per cent reduction in MS relapses.
The latest case of PML came to light after the FDA, together with Elan and its US partner in the development of the drug, Biogen Idec, began a review of the 3,000 patients who had received Tysabri during clinical trials for MS, Crohn's disease and rheumatoid arthritis before it was withdrawn.
While MS patients are disappointed at the news, Orla Hardiman, a consultant neurologist treating MS patients in Beaumont Hospital, Dublin, said there were lots of other MS drugs in the pipeline.
"Although it's a short-term setback, the long-term outlook for MS therapy is very good."
Furthermore, she said, MS treatment wasn't all about drugs. "There is much we can do with services, and we should not take our eye off the fact that there is a dire need for improvement in overall services for people with MS, and that these services are what actually improve people's lives here and now."
MS Ireland's Helpline can be contacted on 1850 233233.