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The FDA approves alemtuzumab in the US for “patients who have had an inadequate response to two or more drugs indicated for the treatment of MS”. See here.
9 September 2014
NHS England confirms that alemtuzumab is now funded on the NHS, including
28 May 2014NICE, confirms that alemtuzumab should be made available for “active relapsing remitting multiple sclerosis”. It should become available in all hoispitals in England and Wales within three months.
07 April 2014Genzyme resubmits to the FDA and drops its appeal (see here).
05 April 2014NICE, the UK body which determines cost-effectiveness of drugs, determines that alemtuzumab should be made available for “active relapsing remitting multiple sclerosis” (see here)
30 December 2013The FDA decided that alemtuzumab should not be approved in the United States (see here). Public details of the FDA meetings can be found here, (under the November 13th meeting). In my opinion, this decision denies people with multiple sclerosis in the United States from an important treatment option.
17 September 2013On September 17th, alemtuzumab iwas licensed as a treatment of “adult patients with relapsing remitting multiple sclerosis with active disease defined by clinical or imaging feature” in Europe, including the UK. It wil not be available on the NHS until it has been assessed by NICE. 27 June 2013 The Committee for Medicinal Products for Human Use, of the EMEA, recommend that alemtuzumab is licensed for the "treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease defined by clinical or imaging features." See here for text.
28 January 2013The US regulatory authority, the FDA, officially accepted the submission for alemtuzumab to be licensed as a treamtent for MS. A decision is expected in on in the second half of 2013
1 November 2012The Lancet publishes the full results of the two phase 3 trials (CARE MSI and CARE MSII) of alemtuzumab in relasing-remitting multiple sclerosis. The results of the trials are summarised here: University of Cambridge news Nature News Blog Some of the press coverage of these trials has focused on the decision of the sponsoring company to withdraw alemtuzumab whilst the licensing process takes place, and its eventual price. Independent article Reuters Lancet editorial
11 October 2012An article and leader in the Independent comments on the withdrawal of alemtuzumab.
12 September 2012First patient received first dose on the CAMTHY trial.
27 August 2012Genzyme announces that it has received a “Refuse to file” notice from the FDA, on the grounds of formatting of the submitted documents. This will delay licensing in the US, but has no impact on the EU licensing process.
9 August 2012Sanofi annouonces that alemtuzumab will no longer be available as a licensed product in the UK. 12 June 2012 Sanofi filed alemtuzumab (trade name Lemtrada) with regulators in the USA and Europe for the treatment of multiple sclerosis. May 2012 Alasdair Coles and Alastair Compston have written three articles on the hisotry of research in multiple sclerosis, entitled, the “Ten Bast Papers in Multiple Sclerosis”, serialised in ACNR. They are available to download here.
April 2012Alasdair Coles and Alastair Compston just after presentation of the CARE-MS1 and CARE-MS2 trial results at the AAN Meeting in New Orleans.
14 November 2014