Genzyme's Lemtrada Approved by the FDA - Approval Establishes Genzyme's MS Franchise in the U.S. with Two Approved Products; Follows Global Approvals - Paris - November 15, 2014 - Sanofi and its subsidiary Genzyme announced today that the U.S. Food and Drug Administration (FDA) has approved LemtradaTM (alemtuzumab) for the treatment of patients with relapsing forms of multiple sclerosis (MS). Because of its safety profile, the use of Lemtrada should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS. "Today's approval is the culmination of more than a decade of work by Genzyme to develop Lemtrada," said Genzyme President and CEO, David Meeker. "Lemtrada demonstrated superior efficacy over Rebif on annualized relapse rates in the two studies which were the basis for approval. A comprehensive risk evaluation and mitigation strategy (REMS) will be instituted in order to help detect and manage the serious risks identified with treatment." The FDA approval of Lemtrada is based on two pivotal randomized Phase III open-label rater-blinded studies comparing treatment with Lemtrada to Rebif (high-dose subcutaneous interferon beta-1a) in patients with relapsing remitting MS who were either new to treatment (CARE-MS I) … Continue reading →

Todays approval is the culmination of more than a decade of work by Genzyme to develop Lemtrada, said Genzyme President and CEO, David Meeker. Lemtrada demonstrated superior efficacy over Rebif on annualized relapse rates in the two studies which were the basis for approval. A comprehensive risk evaluation and mitigation strategy (REMS) will be instituted in order to help detect and manage the serious risks identified with treatment. The FDA approval of Lemtrada is based on two pivotal randomized Phase III open-label rater-blinded studies comparing treatment with Lemtrada to Rebif (high-dose subcutaneous interferon beta-1a) in patients with relapsing remitting MS who were either new to treatment (CARE-MS I) or who had relapsed while on prior therapy (CARE-MS II). In CARE-MS I, Lemtrada was significantly more effective than interferon beta-1a at reducing annualized relapse rates; the difference observed in slowing disability progression did not reach statistical significance. In CARE-MS II, Lemtrada was significantly more effective than interferon beta-1a at reducing annualized relapse rates, and accumulation of disability was significantly slowed in patients given Lemtrada vs. interferon beta-1a. The clinical development program for Lemtrada involved nearly 1,500 patients with more than 6,400 patient-years of safety follow-up. The unmet need in MS remains … Continue reading →

The judge granted the care order for the baby to Tusla until June 30th, 2017, after hearing submissions. Photograph: Alan Betson Tusla, the Child and Family Agency, has been granted a two and a half year care order for a baby boy born earlier this year to a young woman at the centre of the latest abortion controversy. A judge granted the care order for the baby to Tusla until June 30th, 2017, after hearing submissions from lawyers for Tusla, the childs mother, Ms Y, and a Guardian ad Litem appointed by the courts to represent the interests of the child. Tusla had sought a 12-month care order to allow the agency to reassess the situation in a years time and this was not opposed by barrister, Esther Early and solicitor, Caoimhe Haughey, who represented the childs mother, Ms Y. The court heard that both Ms Early and Ms Haughey had been in contact with Ms Y, but were unable to obtain instructions from her with regard to the Tusla application to seek a year-long care order at the expiry of an interim two-month care order granted in September. A solicitor for the Guardian ad Litem also made an application … Continue reading →

The judge granted the care order for the baby to Tusla until June 30th, 2017, after hearing submissions. Photograph: Alan Betson Tusla, the Child and Family Agency, has been granted a two and a half year care order for a baby boy born earlier this year to a young woman at the centre of the latest abortion controversy. A judge granted the care order for the baby to Tusla until June 30th, 2017, after hearing submissions from lawyers for Tusla, the childs mother, Ms Y, and a Guardian ad Litem appointed by the courts to represent the interests of the child. Tusla had sought a 12-month care order to allow the agency to reassess the situation in a years time and this was not opposed by barrister, Esther Early and solicitor, Caoimhe Haughey, who represented the childs mother, Ms Y. The court heard that both Ms Early and Ms Haughey had been in contact with Ms Y, but were unable to obtain instructions from her with regard to the Tusla application to seek a year-long care order at the expiry of an interim two-month care order granted in September. A solicitor for the Guardian ad Litem also made an application … Continue reading →

Federal regulators have approved an injectable multiple sclerosis drug developed by Cambridge biotech Genzyme 10 months after it was initially rejected. Genzyme announced the approval of Lemtrada, a medication to treat patients with relapsing forms of the debilitating disease, last night. Todays approval is the culmination of more than a decade of work by Genzyme to develop Lemtrada, Genzyme President and CEO David Meeker said in a statement. A comprehensive risk evaluation and mitigation strategy will be instituted in order to help detect and manage the serious risks identified with treatment. Lemtrada, which is already sold in Europe, was rejected by the FDA last December after medical experts raised concerns about its safety and the quality of clinical studies. Two new studies comparing Lemtrada to EMD Seronos drug Rebif in patients with relapsing remitting MS who were either new to treatment or who had relapsed while on prior therapy prompted the FDAs course reversal after Lemtrada demonstrated superior efficacy over Rebif on annualized relapse rates, Meeker said. Multiple sclerosis is a chronic, autoimmune condition that affects more than 2 million people worldwide and up to 400,000 in the United States. The FDA approval of Lemtrada is a significant milestone for … Continue reading →