An injectable multiple sclerosis drug developed by Cambridge biotech giant Genzyme was made available to patients in the U.S. for the first time yesterday, less than a month after federal regulators reversed course and approved the medication.
"Lemtrada has changed my life," said Harold Johnson, 44, of Swansea, Ill., who was among the 1,500 MS patients who participated in the drug's clinical development program. "I'm working full time now, I'm married, I can ride my bike on the weekends, I can work out, I can finally be happy."
Johnson, who was diagnosed with MS in 2005, said he "felt almost reborn" just two weeks after receiving his first clinical dose of Lemtrada in March 2009.
"I felt like a new man," Johnson said. "I had a lot more energy, my depression immediately went away and it was replaced with the happiness that continues to this day."
Lemtrada, which is already sold in Europe, Canada and Australia, was initially 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 Serono's drug Rebif led to the medication's approval Nov. 14 for the treatment of American patients with relapsing remitting forms of the debilitating disease.
"My experience with Lemtrada as an MS center director has been quite positive," said Johnson's neurologist, Dr. Barry Singer of Missouri Baptist Medical Center in St. Louis, Mo. "We have really seen the impact where people's lives are more under control — that their lives are regained."
Multiple sclerosis is a chronic, autoimmune condition that affects more than 2 million people worldwide and up to 400,000 in the United States.
Bill Sibold, head of Genzyme's Multiple Sclerosis business, said: "Since approval, we have been singularly focused on providing access as quickly as possible for those patients awaiting Lemtrada by ensuring drug availability, completing required REMS training and certifications, and establishing appropriate patient support."
Anda sedang membaca artikel tentang
U.S. patients get Genzyme drug for MS
Dengan url
http://sedangapasaja.blogspot.com/2014/12/us-patients-get-genzyme-drug-for-ms.html
Anda boleh menyebar luaskannya atau mengcopy paste-nya
U.S. patients get Genzyme drug for MS
namun jangan lupa untuk meletakkan link
U.S. patients get Genzyme drug for MS
sebagai sumbernya
0 komentar:
Posting Komentar