© Website designed by Alasdair Coles, 2012
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”.
9 September 2014
NHS England confirms that alemtuzumab is now funded on the NHS, including
28 May 2014
NICE, 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 2014
Genzyme resubmits to the FDA and drops its appeal (see here).
05 April 2014
NICE, 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 2013
The 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
17 September 2013
On 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 2013
The 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 2012
The 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.
11 October 2012
An article and leader in the Independent comments on the withdrawal of
12 September 2012
First patient received first dose on the CAMTHY trial.
27 August 2012
Genzyme 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 2012
Sanofi 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.
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.
Alasdair 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