- Target:
- Food And Drug Administration
- Region:
- United States of America
- Website:
- www.healthline.com
I would like to thank each of you for your support of this very important petition, Lemtrada. 733 was our final number and I pray that this will make an impact with the FDA to finally approve this much needed treatment for all of us with MS. May God Bless you and keep you all healthy.
Sincerely,
Lisa Dasis
I have been on it for 7 and about to start my 5th dose. Thanks to Genzyme, Lemtrada has been provided to me through a study by my MS Specialist. It has been very successful in reversing a lot of my symptoms by evidence of me being able to get out of a wheel chair and walk independently and reducing the number of exacerbation's.
I feel that 10 years is long enough and that the documentation that has been provided should prevail and be approved. Every treatment option and medication choices should be made by physicians and their patients, not the government.
TO: FOOD AND DRUG ADMINISTRATION
Lemtrada (alemtuzumab) has been used in the USA for over 10 years and in the UK for over 20 years as a study medication for the treatment of multiple sclerosis (MS).
Three successful randomized research trials should improved control of relapse and MRI disease, and 2/3 showed superiority in disability to standard of care of high dose interferon-beta. Lemtrada has been used successfully for many years over in the UK, and often off-label in the US as well for refractory patients. There is not a single specialty expert who questions its efficacy, except at FDA.
The denial of approval based on lack of efficacy in December 2013 denies access for this medication to physicians and doctors. The FDA review process was plainly colored by bureaucracy and inadequate expertise. Despite volumes of data on outstanding efficacy, the FDA committee chose to pursue an agenda to prevent the marketing of the drug, apparently over petty and bureaucratic reasons. The only other country not to approve marketing (UK), did so on the basis of cost of the drug, not its efficacy. Most people with MS in the world currently have access to Lemtrada, except those in the United States.
The FDA has failed us. Mitoxantrone, a truly dangerous drug with 5% of people with life-threatening complications, remains on the market for MS. Tysabri, a similar drug to Lemtrada, which has caused over 400 cases of life-threatening brain infections, remains on the market. Lemtrada is more effective than standard therapy and safer than these medications. There are risks and side effects from all medications on the market and feel that the use of this medication should be decided by the physician and the patient NOT our government. The government should leave decisions on treatment choices that effect our health to patients and physicians.
It is our belief that everyone who suffers from this disabling disease should also have the opportunity to be treated by Lemtrada when medically appropriate. Withholding approval of this unique medication denies people with MS from having the chance to improve their quality of life.
All of us should not have to wait additional time when this medication can make dramatic positive life change for us who suffer with MS. Delays mean disability in MS, we cannot afford to wait any longer.
FDA should put aside the pettiness and obstacles to therapy for the people with MS, their physicians, and the companies making application for its approval. It needs to reverse its decision and approve the drug.
The Lemtrada for FDA Approval for Treatment of Multiple Sclerosis petition to Food And Drug Administration was written by Lisa Dasis and is in the category Health at GoPetition.