PHARMACY

Sanofi sues Novo Nordisk over diabetes drug availability claims

BY Brian Berk

BRIDGEWATER, N.J. — Sanofi filed a lawsuit against Novo Nordisk for allegedly falsely claiming Sanofi insulin drugs would no longer be available for many U.S. patients, in an effort to promote Novo Nordisk’s competing drug, Reuters reported.

The suit, filed on Dec. 23 by Sanofi U.S. in the U.S. District Court for the District of New Jersey, seeks an order requiring Novo Nordisk to pay unspecified monetary damages and withdraw marketing materials for its drug Tresiba, the news outlet reported. The marketing materials allegedly ask patients and doctors to switch from Sanofi’s Lantus and Toujeo drugs, used to treat diabetes, to Tresiba, because the Sanofi drugs will be “blocked” by pharmacy benefit manager CVS Caremark in January.

“(W)e believe Novo’s statements concerning CVS Caremark’s formulary decision on Lantus and Toujeo coverage contain false and misleading claims about the continued availability of Lantus and Toujeo,” a Sanofi spokesperson told Reuters.

Novo Nordisk had no comment when reached by the news source. 

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FDA approves Biogen’s spinal muscular atrophy drug

BY Brian Berk

WASHINGTON, D.C. — The U.S. Food and Drug Administration approved Biogen’s Spinraza (nusinersen), the first drug approved to treat children and adults with spinal muscular atrophy (SMA), a rare and often fatal genetic disease affecting muscle strength and movement.

“There has been a long-standing need for a treatment for spinal muscular atrophy, the most common genetic cause of death in infants, and a disease that can affect people at any stage of life,” said Billy Dunn, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “As shown by our suggestion to the sponsor to analyze the results of the study earlier than planned, the FDA is committed to assisting with the development and approval of safe and effective drugs for rare diseases and we worked hard to review this application quickly; we could not be more pleased to have the first approved treatment for this debilitating disease.”

SMA is a hereditary disease that causes weakness and muscle wasting because of the loss of lower motor neurons controlling movement. There is wide variability in age of onset, symptoms and rate of progression. Spinraza is approved for use across the range of spinal muscular atrophy patients.

Spinraza is an injection administered into the fluid surrounding the spinal cord. The efficacy of Spinraza was demonstrated in a clinical trial in 121 patients with infantile-onset SMA who were diagnosed before 6 months of age and who were less than 7 months old at the time of their first dose. Patients were randomized to receive an injection of Spinraza, into the fluid surrounding the spinal cord, or undergo a mock procedure without drug injection (a skin prick). Twice the number of patients received Spinraza compared to those who underwent the mock procedure. The trial assessed the percentage of patients with improvement in motor milestones, such as head control, sitting, ability to kick in supine position, rolling, crawling, standing and walking.

The FDA granted this application fast track designation and priority review. The drug also received orphan drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.

According to the FDA, the most common side effects found in participants in the clinical trials on Spinraza were upper respiratory infection, lower respiratory infection and constipation. Warnings and precautions include low blood platelet count and toxicity to the kidneys (renal toxicity). Toxicity in the nervous system (neurotoxicity) was observed in animal studies.

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Bristol-Myers Squibb CEO Caforio to add chairman to his title

BY Brian Berk

NEW YORK — Bristol-Myers Squibb announced CEO Giovanni Caforio, M.D., will add chairman to his title. Caforio will assume the role on May 2, succeeding Lamberto Andreotti, who will retire as chairman.

Caforio has been chief executive officer of Bristol-Myers Squibb since May 2015 and has been serving on the company’s Board of Directors since June 2014.

“It is an honor to have the opportunity to build on the strong foundation established by Lamberto Andreotti,” said Caforio. “Bristol-Myers Squibb has tremendous opportunities for growth, highlighted by our leadership position in Immuno-Oncology and the opportunity to accelerate our diversified pipeline of transformational medicines. Working with the talented leaders and employees of this company, I look forward to further advancing our BioPharma strategy, and delivering transformational medicines that make a difference in the lives of patients around the world.”

Andreotti served as Bristol-Myers Squibb’s CEO from 2010 through May 2015 and will have served as Bristol-Myers Squibb’s chairman for two years when Caforio’s appointment becomes effective in May 2017.

“Since being named CEO, Giovanni has clearly demonstrated the capabilities needed to lead Bristol-Myers Squibb in the near and long term,” said Andreotti. “It was a pleasure working with Giovanni during this transition period, and I have full confidence that he will do what is needed to continue to deliver on the company’s mission and generate sustainable growth for our shareholders now and in the future.”

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