Enbrel drug shortage – but Remicade imminent
Reproduced from Issue 108 of Arthritis Today
Thousands of rheumatoid arthritis patients in the UK will be unable to get hold of one of the two new biologic drugs at least until the end of the year – because the drug company manufacturing it has run out of supplies.
Wyeth, UK producers of Enbrel, blame the "serious shortfall" of supplies on excessive demand for the drug in the US, which exceeded their earlier expectations. Around 50,000 rheumatoid arthritis patients are taking Enbrel in the States.
Instead the company now plans to make the drug available only to children with polyarticular juvenile chronic arthritis for the short to medium term. A small number of adults who are already taking the drug on a compassionate basis will also continue to receive it.
Dr David Doyle, a rheumatologist at Whipps Cross Hospital, and a member of the British Society of Rheumatology's new therapies working party, set up to issue clinical guidelines to his colleagues on the new biologics, said the news was very disappointing.
"We had been looking forward to the advent of this exciting new treatment and it's extremely disappointing that because of supply reasons that we are not going to have access to this drug for the foreseeable future," he said.
Wyeth spokesman David Gibbons said they were doing everything they could to ensure that Enbrel was available as soon as possible. "It's our number one priority," he added. "The existing factory is gearing up to increase production, and we have just bought a new manufacturing plant in the east coast of the States – but it takes time for this to come on line.
"It's disappointing for patients who have been waiting for such a long time for this drug, but in the mean time we hope they can get benefit from an alternative product, which is expected to be licensed shortly."
The alternative product Remicade, expected to be licensed between April and June, is continuing to arouse expectation among doctors and patients, especially with the latest reports that the anti-TNF drug used in combination with methotrexate actually stops the progression of joint destruction within six months, as well as having a beneficial effect on patients' wellbeing.
It is likely to be suitable for around 12,000 patients in the UK who have severe, long-established RA, who have failed to respond to two or more existing disease-modifying drugs, including methotrexate.
Unfortunately, at around £9,000 a year for a year's supply – compared to a few hundred pounds for currently-used DMARDs – many health authorities may be unwilling to pay for its use in more than a handful of patients.
arc, which carried out the pioneering anti-TNF research at the Kennedy Institute which directly led to the development of Remicade, wants the drug to be made as widely available as possible.
Fergus Logan
"The basic science conducted at the Kennedy Institute wholly underpinned the development of Remicade," said chief executive Fergus Logan.
"It is immensely gratifying when the hard work and generosity of so many fundraisers and donors bears fruit like this. Many have been devoted to the cause for years, and they will rightly be delighted to have contributed to such an advance.
"It is vital, of course, that this new treatment should be readily available to everyone who would benefit – and clearly costs are likely to be an issue. We think it is important that drug manufacturers and funders should examine ways in which any problems might be overcome – and this will probably require flexibility and imagination on both sides."
