PHARMACY

FDA approves Saxenda from Novo Nordisk

BY Ryan Chavis

PLAINSBORO, N.J. — Novo Nordisk last week announced that the Food and Drug Administration approved the company's new drug application for Saxenda (liraglutide [rDNA origin] injection). The once-daily glucagon-like peptide-1 receptor agonist is used as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adults with obesity or who are overweight in the presence of at least one weight-related comorbid condition, the company stated. 
 
"Many people with obesity suffer from comorbidities. Saxenda has the potential to help some of these people achieve and maintain a clinically significant weight loss and improve certain risk factors of weight-related comorbidities," said Mads Krogsgaard Thomsen, EVP and chief science officer of Novo Nordisk.
 
Approximately one-third of the adult population lives with obesity, the company stated, which can put them at risk to a number of health problems. 
 
"Obesity has many root causes and there is a clear need for additional treatment options to help health care professionals better address our patients' individual conditions and goals for weight management," said Dr. Donna Ryan, professor and associate executive director of clinical research at the Pennington Biomedical Research Center. "The approval of Saxenda provides us with a new therapeutic approach for helping our patients achieve and maintain a healthier body weight." 
 
The company said it expects to launch Saxenda in the United States in the first half of 2015.

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Actavis, Adamas approved for Namzaric

BY Ryan Chavis

DUBLIN and EMERYVILLE, Calif. — Actavis and Adamas Pharmaceuticals last week announced that the Food and Drug Administration approved Namzaric. According to the companies, the drug is used to treat moderate to severe dementia of the Alzheimer's type in patients stablized on memantine hydrochloride and donepezil hydrochloride.
 
"Namzaric combines, in one capsule, two complementary therapeutic agents which are often co-prescribed as approximately 70% of Namenda XR patients are also on AChEI therapy.  Both Namenda XR and donepezil have proven efficacy and safety, for the treatment of moderate to severe Alzheimer's disease. Additionally, data has shown that combination therapy with Namenda XR and an AChEI demonstrated greater improvement in cognition and global function verses an AChEI alone," said David Nicholson, Actavis SVP, global brands research and development. "Along with our partner Adamas, we are proud that this important therapy will provide a convenient and innovative treatment option for Alzheimer's patients and caregivers that reduces the number of capsules they are required to take each day for the treatment of this devastating disease."
 
Namzaric was formerly known as MDX-8704. It's a once-daily oral capsule indicated for patients currently taking memantine (10 mg twice daily or 28 mg extended-release once-daily) and donepezil in 10-mg dosage strength. The capsules can be open to allow the contents to be sprinkled on food for patients who have trouble swallowing. Namzaric will be available in two dosage strengths: 28/10 mg (memantine extended release/donepezil) and 14/10mg (memantine extended release/donepezil.)
 
"We are excited about the approval of Namzaric — the first fixed-dose combination of extended-release memantine and donepezil — and look forward to its launch by Actavis in 2015," said Gregory Went, Ph.D., chairman and CEO of Adamas Pharmaceuticals. "Namzaric is also the first FDA-approved FDC product to emerge from Adamas' platform for modifying the pharmacokinetic profiles of approved drugs, and we look forward to developing additional new treatments for individuals with serious neurological CNS disorders."

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W.Dodds says:
Dec-31-2014 09:30 pm

Namzaric - a new Alzehimer's drug which is NOT NEW - just a combination of Namenda and Aricept. And the FDA approves of course. With all due respect to the FDA and Actavis, BALONEY. I am really glad that Actavis will have a product to sell, and they have a business to run. But most of the time, Namenda and Aricept do nothing. They provide some very limited support in the EARLY stages of Alzheimer's Disease, if that. I would view them as really really WORTHLESS. We have this incredibly serious epidemic of a terminal disease that totally destroys the brains of our Americans, and we are given these medications which are barely above an aspirin or a placebo, and we are announcing these as progress. It is not only unconscionable and unethical, future generations would look back on such failures as actually criminal. It is astounding that publications can release such PR press releases, which Actavis of course, has every to do, without any context on these serious health and medical ethical issues. I can only imagine what the next generation looking back is going to say about all this.

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Diplomat’s Hagerman to be inducted as 2015 Michigan Pharmacists Association president

BY Antoinette Alexander

FLINT, Mich. — Diplomat Pharmacy announced that Jennifer Hagerman, senior director of education and quality at Diplomat, will take office as the president of the Michigan Pharmacists Association on Jan. 1.

The formal induction ceremony will take place Feb. 28 at the MPA Annual Convention and Exposition, which will be held at the Renaissance Center in Detroit. Hagerman will be the association's 131st president.

Hagerman will serve a one-year term as president, followed by a one-year term as chairman of the board, guiding the organization as it supports Michigan's pharmacists, pharmacy technicians and student pharmacists. As MPA president she will guide the establishment of the Association's goals and objectives for the year, provide leadership to the executive board and MPA membership and serve as a spokesperson for the Association.

"Michigan Pharmacists Association has a long history of successfully advocating for and providing a unified voice for the profession of pharmacy in Michigan. As president of the association I am honored to have an opportunity to continue that legacy," Hagerman said. "I look forward to the many opportunities that lie ahead for the pharmacy profession and the role that the MPA can play in optimizing the role of the pharmacist within the health care team."

At Diplomat, Hagerman directs the Diplomat University, providing specialized training to both Diplomat employees and external professionals seeking education in the specialty pharmacy industry. Hagerman also oversees the company's quality assurance program and serves as the director of Diplomat's Postgraduate Year One Pharmacy Residency Program, which is accredited by the American Society of Health-System Pharmacists.

She is also chair of the National Association of Specialty Pharmacy Educational Affairs Committee, secretary for the Pharmacy Education Development and Lecture Series Committee and executive board liaison for the Genesee County Pharmacists Association. 
 

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