State Animal Health Lab Bill Introduced By Senate Appropriations Committee

February 2, 02017

PIERRE, S.D. – The Senate Appropriations Committee today introduced a bill on behalf of Gov. Dennis Daugaard to fund an upgrade and expansion to the state animal disease research and diagnostic laboratory. Located on the campus of South Dakota State University, the facility serves as the state animal health laboratory.

The lab develops and conducts tests to identify animal diseases, creates new protocols to distinguish unique disease strains, and develops vaccines and other treatments to directly assist veterinarians, ranchers, farmers, pet owners, wildlife managers, public health officials, and state and federal agencies.

“When disease outbreaks risk the production of our food and the health of our citizens, a timely, accurate diagnosis of the cause is essential,” Gov. Daugaard said. “I look forward to working with the Legislature, agriculture industry and SDSU to sustain this public-private partnership and upgrade and expand the lab.”

The lab was built in 1967 and last upgraded in 1993. It is out-of-date, according to the Governor, and needs to be modernized to correct aging infrastructure, accommodate new technologies, and meet current and future health and safety standards

“The lab is key to securing the livestock sector’s long-term viability, not just for South Dakota, but for the entire region,” Senate President Pro Tempore Brock Greenfield said. “Its economic impact extends to agriculture and beyond.”

Lab staff have been involved in combating significant livestock diseases, including porcine endemic diarrhea virus in 2013 and avian influenza in 2015. In the early 1980s, the lab identified a previously unknown swine virus and developed a widely used vaccine to prevent it.

“Agriculture is South Dakota’s No. 1 industry,” added House Majority Leader Lee Qualm. “The lab provides critical research and diagnostic support to protect our citizens and livestock industry from disease outbreaks.”

In addition to proposed funding from the state general fund, the bill includes several agriculture-related fees to cover much of the $3 million per year bond payment.

“We all know the value of the lab to South Dakota livestock producers,” South Dakota Pork Producers Executive Director Glenn Muller said. “The key now is finding the right funding mix to get this done.”

“This is a good first step,” South Dakota Cattlemen’s Association President Larry Stomprud added. “The agriculture industry will be at the table, and we look forward to continued discussions on funding mechanisms.”

FDA Approves First Drug For Spinal Muscular Atrophy

December 23, 2016

SILVER SPRINGS, MD – The U.S. Food and Drug Administration today approved 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. Spinraza is an injection administered into the fluid surrounding the spinal cord.

“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 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.

The FDA worked closely with the sponsor during development to help design and implement the analysis upon which this approval was based. 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 asked the sponsor to conduct an interim analysis as a way to evaluate the study results as early as possible; 82 of 121 patients were eligible for this analysis. Forty percent of patients treated with Spinraza achieved improvement in motor milestones as defined in the study, whereas none of the control patients did.

Additional open-label uncontrolled clinical studies were conducted in symptomatic patients who ranged in age from 30 days to 15 years at the time of the first dose, and in presymptomatic patients who ranged in age from 8 days to 42 days at the time of first dose. These studies lacked control groups and therefore were more difficult to interpret than the controlled study, but the findings appeared generally supportive of the clinical efficacy demonstrated in the controlled clinical trial in infantile-onset patients.

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.

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.

The sponsor is receiving a rare pediatric disease priority review voucher under a program intended to encourage development of new drugs and biologics for the prevention and treatment of rare pediatric diseases. A voucher can be redeemed by a sponsor at a later date to receive priority review of a subsequent marketing application for a different product. This is the eighth rare pediatric disease priority review voucher issued by the FDA since the program began.

Spinraza is marketed by Biogen of Cambridge, Massachusetts and was developed by Ionis Pharmaceuticals of Carlsbad, California.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.