Biogen Idec today announced that Fampyra® (prolonged-release fampridine tablets) has been made available in Ireland for the symptomatic treatment of walking impairment in adults with Multiple Sclerosis (MS). Fampyra is a prescription drug and is licensed for use in all types of the disease, including the progressive forms. FAMPYRA is available by way of retail pharmacy on a private payment basis. Fampyra is not currently available for reimbursement through any of the Health Service Executive’s (HSE’s) payment schemes.
“We are very pleased that Fampyra is now available for use in Ireland”, said Terry O’Regan, Vice President & Managing Director of Biogen Idec Ltd. “As a leading company in MS, we feel a strong sense of obligation to the MS community to bring new and innovative therapies to the people that need them, and we’re absolutely delighted to be able to offer this new treatment option for MS patients with walking disability.”
“Walking and mobility are the number one concerns for people with MS, so a therapy that potentially offers an improvement is a valued and welcomed addition to the treatment options available”, said Doctor Christopher McGuigan, Consultant Neurologist, St. Vincent's Hospital, Dublin. Dr. McGuigan is one of a number of healthcare professionals in Ireland who has previous experience with Fampyra as a participant in clinical trials, and via the Named Patient Supply programme. In clinical trials, Fampyra demonstrated efficacy in improving walking speed. In the pivotal MS-F203 phase III study by Goodman et al, around 35% of patients taking FAMPYRA responded to treatment compared with 8% of patients taking placebo. In the second study, the results were similar with 43% of patients in the Fampyra group responding to treatment compared with 9% in the placebo group.
Fampyra is not reimbursed by the Health Service Executive (HSE), however, Biogen Idec is providing up to four weeks’ treatment of Fampyra at no cost, enabling clinicians and patients to trial the product and assess its effectiveness before committing to pay for treatment. Treatment effect is usually evident between two to four weeks.
Fampyra is currently available throughout most of Europe.
Source: MarketWatch Copyright © 2014 MarketWatch (15/01/14)
Acorda Therapeutics, Inc. today announced safety data from more than 62,400 people with multiple sclerosis (MS) taking Ampyra (dalfampridine) Extended Release Tablets, 10 mg during the first two years of availability in the United States. The data showed that the safety profile of Ampyra is similar to that observed in clinical trials.
This analysis was presented at the 28th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), being held in Lyon, France from October 10-13. Ampyra is known as prolonged-, modified, or sustained-release fampridine (Fampyra®) in some countries outside the United States.
The analysis examined all post-marketing adverse events (AEs) that were reported to Acorda and the U.S. Food and Drug Administration (FDA) from March 2010 through March 2012. As is typical in post-marking data collection, there is a potential for underreporting of AEs. Key findings included:
Among the 62,400 patients who were prescribed Ampyra during the first two years following FDA approval, 160 seizures were reported, or approximately 4.6 per 1000 patient-years of use. This rate is comparable to the rate of seizure seen in the overall MS population. Length of treatment prior to a seizure ranged from first dose to two years, with 20% of the seizures occurring within a week of starting treatment. Because of their disease, people with MS are at a higher risk of seizure than people who do not have MS.
The most frequently reported AEs from March 2010 through March 2012 were dizziness, insomnia, balance disorder, headache, nausea, urinary tract infection, back pain, and asthenia. These are similar to the AEs most frequently reported during Ampyra clinical trials.
"Ampyra has been available for over two years in the United States, providing us with safety data from real-world use by people with MS. These data showed that the safety profile of Ampyra in clinical practice is consistent with what was observed in clinical trials," said Enrique Carrazana, M.D., Acorda Therapeutics' Chief Medical Officer. "The data also indicate the rate of seizure has remained consistent over time, and is within the range that is expected in the overall MS population."
This poster presentation was sponsored by Acorda Therapeutics, Inc. In markets outside of the United States, Ampyra is available as Fampyra. Fampyra is being developed and commercialized by Biogen Idec in these markets based on a licensing agreement with Acorda.
Source: Daily Finance © Copyright 2012 AOL Inc (10/10/12)
Drug manufacturer did not present evaluable study data on the appropriate comparator therapy.
Fampridine (trade name Fampyra®) has been approved in Germany since July 2011 for adult patients suffering from a higher grade walking disability (grades 4 to 7 on the EDSS disability status scale), as a result of multiple sclerosis (MS). The German Institute for Quality and Efficiency in Health Care (IQWiG) has assessed the added benefit of the drug pursuant to the Act on the Reform of the Market for Medicinal Products (AMNOG). According to the findings, there is no proof of added benefit, as the manufacturer's dossier contains no evaluable study data for the comparison between fampridine and the appropriate comparator therapy.
G-BA specifies physiotherapy as the appropriate comparator therapy.
MS is a chronic incurable inflammatory disease, in which the patient's own immune system damages nerve tracts in the brain and spinal cord. In some patients, some muscles are in permanent spasm or are paralysed. If the disease is more advanced, patients may develop a walking disability.
The Federal Joint Committee (G-BA) has specified physiotherapy as the appropriate comparator therapy for the benefit assessment. This treatment must fulfil the requirements of the German Guideline on Remedies (Heilmittelrichtlinie). In addition, the patients must receive optimised standard therapy for MS.
Requirements for an indirect comparison not fulfilled.
There are no studies that directly compare fampridine with physiotherapy. Instead, the pharmaceutical company presented data on an indirect comparison. These data originate from studies in which fampridine was compared with a placebo or in which physiotherapy was compared with "no treatment".
The legal ordinance on AMNOG explicitly specifies that it is possible to prove added benefit using indirect comparisons too. However, specific methodological conditions apply, which were not fulfilled by the manufacturer in the fampridine dossier.
Marked differences in the grade of disability
In addition, the studies on physiotherapy which the pharmaceutical company has evaluated cannot be used, as they also included patients with a markedly lower grade of disability (EDSS from 1.5) than in the studies on fampridine. Thus, the populations were not similar enough to allow a comparison between the results.
Finally, the manufacturer does not discuss in the dossier whether the physiotherapy tested in these studies was in accordance with the criteria of the Guideline on Remedies and, if this is not the case, why these studies would nevertheless allow conclusions about the situation in Germany. Moreover, the manufacturer does not mention whether the patients actually received optimized MS standard therapy. However, these two points are conditions specified by the G-BA for the appropriate comparator therapy.
Hence the manufacturer did not present evaluable studies on the appropriate comparator therapy for the assessment of the added benefit of fampridine, thereby also failing to present an evaluable indirect comparison. Thus there is no proof of added benefit of fampridine.
G-BA decides on the extent of added benefit.
The dossier assessment is part of the overall procedure for early benefit assessment conducted by the G-BA. After publication of the manufacturer's dossier and its assessment by IQWiG, the G-BA initiates a formal commenting procedure which provides further information and can result in a change to the benefit assessment. The G-BA then decides on the extent of the added benefit, thus completing the early benefit assessment.
Source: Medical News Today © MediLexicon International Ltd 2004-2012 (01/09/12)
Acorda Therapeutics, Inc. announced top line results from a post-marketing commitment study assessing a 5mg dose of dalfampridine-ER to improve walking in people with multiple sclerosis, or MS. The study failed to confirm efficacy of the 5mg dose.
According to the company, the study randomized 430 participants across three treatment arms - placebo, 5 mg or the currently marketed dose of 10 mg of dalfampridine-ER, twice daily. Baseline characteristics were measured at a single visit after randomization, following a qualifying screening visit. Study drug was then given for 4 weeks. Participants returned after 2 weeks on study drug for interim measurements (Visit 2) and again at 4 weeks (Visit 3).
Acorda noted that the primary outcome was the change in walking speed (feet/second) on the Timed 25-Foot Walk test at Visit 3, measured at the time of peak plasma drug concentration, versus baseline. Improvements in the primary outcome for the 5 mg dose and the 10 mg dose at Visit 3 were not statistically significant compared to placebo, the company added.
Source: RTT News Copyright © 2012 RTTNews (13/08/12)