Genzyme’s LEMTRADA™ application for MS accepted for review by the FDA
Posted: 28 January 2013 | | No comments yet
Genzyme also reports very encouraging early launch indicators for AUBAGIO® (teriflunomide) in U.S.
Sanofi (EURONEXT: SAN and NYSE: SNY) and its subsidiary Genzyme announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s supplemental Biologics License Application (sBLA) file seeking approval of LEMTRADATM (alemtuzumab) for the treatment of relapsing multiple sclerosis (RMS). The company also reported key highlights from the U.S. launch of once-daily, oral AUBAGIO (teriflunomide).
LEMTRADA sBLA Accepted by FDA
The FDA has accepted for standard review the company’s sBLA file seeking approval of LEMTRADA. Genzyme expects FDA action on the application in the second half of 2013. Genzyme has already submitted its marketing authorization application for LEMTRADA to the European Medicines Agency (EMA) and the review process is underway. The Committee for Medicinal Products for Human Use (CHMP) opinion for LEMTRADA is expected in Q2 2013.
The LEMTRADA clinical development program includes CARE-MS I and CARE-MS II (Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis), randomized Phase III studies comparing LEMTRADA to a standard of care MS treatment, Rebif, in patients with relapsing-remitting MS who were naïve to prior treatment or who had relapsed while on prior therapy, respectively. Genzyme announced publication of results of these studies in The Lancet in November 2012.
AUBAGIO Early Launch Indicators in the U.S.
Since its launch in October, once-daily, oral AUBAGIO has shown very encouraging early launch indicators among U.S. prescribers.1 Key highlights from the launch include:
- More than 80 percent of MS specialists in the U.S. have prescribed AUBAGIO;
- Approximately 1 in 5 patients prescribed AUBAGIO were treatment-naïve;
- More than 50 percent of AUBAGIO patients were most recently on Copaxone® and Avonex®
“Genzyme is making a difference for people living with MS and realizing its vision of being leaders in MS,” said Genzyme President and CEO, David Meeker, M.D. “The initial uptake of AUBAGIO by U.S. prescribers shows the importance of a once-daily oral option in MS. In addition, the acceptance of the LEMTRADA file in the U.S. marks another important milestone in bringing this potentially transformative therapy to MS patients. We look forward to a series of product launches in 2013 in Europe and other major markets.”
AUBAGIO is approved for use in both the U.S. and Australia.
About Alemtuzumab/LEMTRADA™
Alemtuzumab is a monoclonal antibody that selectively targets CD52, a protein abundant on T and B cells. Treatment with alemtuzumab results in the depletion of circulating T and B cells thought to be responsible for the damaging inflammatory process in MS. Alemtuzumab has minimal impact on other immune cells. The acute anti-inflammatory effect of alemtuzumab is immediately followed by the onset of a distinctive pattern of T and B cell repopulation that continues over time, rebalancing the immune system in a way that potentially reduces MS disease activity.
Genzyme holds the worldwide rights to alemtuzumab and has primary responsibility for its development and commercialization in multiple sclerosis. Bayer HealthCare retains an option to co-promote alemtuzumab in multiple sclerosis. Bayer HealthCare has notified Genzyme of its intention to copromote under this option. Upon regulatory approval and commercialization, Bayer would receive contingent payments based on sales revenue.
Lemtrada is the proprietary name submitted to health authorities for the company’s investigational multiple sclerosis agent alemtuzumab.
About AUBAGIO®
AUBAGIO is an immunomodulator with anti-inflammatory properties. Although the exact mechanism of action for AUBAGIO is not fully understood, it may involve a reduction in the number of activated lymphocytes in the central nervous system (CNS).
Indications and Usage
AUBAGIO (teriflunomide) is s a once-daily, oral treatment indicated for patients with relapsing forms of multiple sclerosis (MS). AUBAGIO 14 mg has shown significant efficacy across key measures of MS disease activity, including reducing relapses, slowing the progression of physical disability, and reducing the number of brain lesions as detected by MRI.
Important Safety Information About AUBAGIO
The AUBAGIO label includes a boxed warning citing the risk of hepatotoxicity and, teratogenicity (based on animal data).
In MS clinical studies with AUBAGIO, the incidence of serious adverse events were similar among AUBAGIO and placebo-treated patients. The most common adverse events associated with AUBAGIO in MS patients included increased ALT levels, alopecia, diarrhea, influenza, nausea and paresthesia.
Teriflunomide is the principal active metabolite of leflunomide, which is indicated in the U.S. for the treatment of rheumatoid arthritis. Severe liver injury including fatal liver failure has been reported in patients treated with leflunomide.
Leflunomide has an estimated 2.1 million years of patient exposure in rheumatoid arthritis globally since its launch.
AUBAGIO is contraindicated in pregnant women and women of childbearing potential who are not using reliable contraception.
AUBAGIO is supported by a robust clinical program with more than 5,000 trial participants in 36 countries and is amongst the largest of any MS therapy. Some patients in extension trials have been treated for up to 10 years. The AUBAGIO approvals were based on efficacy data from the TEMSO (TEriflunomide Multiple Sclerosis Oral) trial.
For full prescribing information and more information about AUBAGIO, please visit www.genzyme.com.
Reference
- Based on data collected at Genzyme’s MS One to One Patient and Provider Support Center, September 2012-January 2013.
