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A board to discuss the soon-to-be released drug Campath as a treatment for Multiple Sclerosis

MS drug Lemtrada investigators protest FDA decision

Several multiple sclerosis (MS) experts who were involved in the clinical development program for alemtuzumab (Lemtrada, Genzyme) have voiced their disappointment and frustration over the recent decision by the US Food and Drug Administration (FDA) not to approve the drug.

Stephen Krieger, MD, from Mount Sinai Medical Center, New York; Edward Fox, MD, from the Multiple Sclerosis Clinic of Central Texas, Round Rock; and Jeffrey Cohen, MD, from Cleveland Clinic, Ohio, all told Medscape Medical ...
Read more : MS drug Lemtrada investigators protest FDA decision | Views : 697 | Replies : 1


Sanofi faces U.S. class action over MS drug Lemtrada

A U.S. law firm is launching a class action against France's Sanofi over what it calls misleading statements on the safety and efficacy of its multiple sclerosis drug Lemtrada.

Sanofi acquired Lemtrada when it bought U.S. biotech firm Genzyme for $20.1 billion in 2011. The drug's prospects took center-stage in a drawn-out takeover battle and led to a deal in which Genzyme shareholders received listed contingent value rights (CVRs) linked to Lemtrada's future success...... Read ...
Read more : Sanofi faces U.S. class action over MS drug Lemtrada | Views : 737 | Replies : 0


MS drug Lemtrada approved in Australia

Genzyme, a Sanofi company, has announced that the Australian Therapeutic Goods Administration (TGA) has approved Lemtrada (alemtuzumab) for the treatment of relapsing forms of multiple sclerosis for patients with active disease defined by clinical or imaging features to slow the accumulation of physical disability and reduce the frequency of clinical relapses.......... Read More - http://www.ms-uk.org/lemtrada
Read more : MS drug Lemtrada approved in Australia | Views : 821 | Replies : 1


Lemtrada approved in Canada for treatment of MS

Genzyme, a Sanofi company, announced today that Health Canada has approved Lemtrada (alemtuzumab) for the management of adult patients with relapsing remitting multiple sclerosis (RRMS), with active disease defined by clinical and imaging features, who have had an inadequate response to interferon beta or other disease-modifying therapies........ Read More - http://www.ms-uk.org/lemtrada
Read more : Lemtrada approved in Canada for treatment of MS | Views : 747 | Replies : 1


MS drug Lemtrada does not benefit patients, FDA panel says

Lemtrada hasn’t proven to help against disability in the treatment of relapsing multiple sclerosis, said U.S. advisers who questioned whether the company’s studies were conducted well enough to assess the drug.

While the U.S. Food and Drug Administration advisory panel decided that potential safety risks don’t preclude approval of Lemtrada, its members voted 14-2 that the drug didn’t help improve a patient’s disability. The agency isn’t required to accept the recommendations of its advisers..... Read ...
Read more : MS drug Lemtrada does not benefit patients, FDA panel says | Views : 782 | Replies : 0


FDA staff says new oral MS drug Lemtrada may be too risky

Sanofi’s multiple sclerosis treatment Lemtrada may not offer enough benefit to patients to outweigh risks including cancer, U.S. regulators said. The French drugmaker’s shares fell.

Lemtrada’s “serious and potentially fatal safety issues,” which include the risk of autoimmune and thyroid diseases, may make the medicine too dangerous to approve unless there is substantial clinical benefit shown, Food and Drug Administration staff said in a report today. Agency reviewers also questioned whether Sanofi conducted adequate trials ...
Read more : FDA staff says new oral MS drug Lemtrada may be too risky | Views : 924 | Replies : 1


Alemtuzumab 3-year data show durable effect on MS disability

Latest data from the CARE-MS II extension study show that alemtuzumab (Lemtrada, Genzyme/Sanofi) has a durable effect on disability in multiple sclerosis (MS), with the mean Expanded Disability Status Scale (EDSS) score at 3 years still below that at baseline.<br><br>

These new data were presented in a poster at the 29th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) last week...... Read More - http://www.ms-uk.org/lemtrada
Read more : Alemtuzumab 3-year data show durable effect on MS disability | Views : 892 | Replies : 0


Oral MS drug Lemtrada approved by European Commission

Genzyme, a Sanofi company announced today that the European Commission has granted marketing authorization for Lemtrada(TM). This follows the August 30th approval of Aubagio(R). The company intends to begin launching both products in the EU soon.

"The approvals of Lemtrada and Aubagio in the European Union represent an important milestone for Genzyme and demonstrate our focus on scientific innovation and commitment to multiple sclerosis patients," said Genzyme CEO and President, David Meeker, M.D. "This is ...
Read more : Oral MS drug Lemtrada approved by European Commission | Views : 998 | Replies : 1


Got all it's gonna give me

I went to my neuro clinic for my monthly blood draw. The trial coordinator asked me how I was doing since my last dose of alemtuzumab (it's been over a year and I've dosed four times in total). I told her that I was slowly declining and she said that I should begin to look at other treatment options, that alemtuzumab had done all its going to do for me. I can continue and should ...
Read more : Got all it's gonna give me | Views : 1326 | Replies : 1


Genzyme receives positive CHMP opinion for Lemtrada™

Genzyme receives positive CHMP opinion for Lemtrada™ (alemtuzumab) in Europe

CHMP also Recommends NAS Designation for Aubagio® (teriflunomide) Following Positive Opinion on Approval in March 2013

Genzyme announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for approval of Lemtrada™ (alemtuzumab) for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease defined by clinical or imaging ...
Read more : Genzyme receives positive CHMP opinion for Lemtrada™ | Views : 972 | Replies : 0


 

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