Boehringer Ingelheim receives FDA approval for SENVELGO® (velagliflozin oral solution): the first oral liquid medication for diabetes in cats

• SENVELGO^® (velagliflozin oral solution) is the first liquid once-daily, orally administered prescription medication to improve glycemic control in cats with diabetes mellitus
• While current treatment regimens are complex, SENVELGO^® oral solution makes treating feline diabetes simple and convenient for both cats and cat owners

DULUTH, Ga., Aug. 14, 2023 /PRNewswire/ -- Boehringer Ingelheim announced today that SENVELGO^® (velagliflozin oral solution), a revolutionary new treatment for cats with diabetes, has been approved by the U.S. Food and Drug Administration (FDA). SENVELGO^® is a once-daily liquid oral solution that cat owners can give with a small amount of food or directly into the cat's mouth. 

Feline diabetes is one of the most common endocrine disorders in cats,¹ with studies showing that up to 30% of diagnosed cats are left untreated due to the complexities of existing treatments.² 

Up to one in three diabetic cats is euthanized within the first year of diagnosis and the complexity required to treat diabetic cats is often a contributing factor.² SENVELGO^® oral solution simplifies the treatment process and removes the need for needles to improve glycemic control in cats with diabetes mellitus not previously treated with insulin.

Dr. Cynthia Ward, Professor Emerita of Internal Medicine at the University of Georgia and member of the U.S. Boehringer Ingelheim Diabetes Advisory Board says, "SENVELGO^® oral solution is a game-changer that will revolutionize the management of feline diabetes. It significantly eases the complexity of feline diabetes treatment and is easy to administer. In addition, SENVELGO^® oral solution makes it simpler to successfully monitor treatment and makes time-intensive blood glucose curve monitoring redundant."

As soon as one week after beginning treatment, SENVELGO® oral solution improves the clinical signs of diabetes that cats experience by reducing elevated blood glucose levels and minimizing the risk of clinical hypoglycemic events.³ The novel drug comes in liquid form, the formulation that cats and cat owners prefer, according to studies.^{4, 5}

Daniel Watkins, Head of U.S. Pet at Boehringer Ingelheim says, "At Boehringer Ingelheim, we are passionate about improving the health and wellbeing of animals. SENVELGO^® oral solution is a convenient feline therapeutic product and demonstrates our dedication to continuously deliver and drive new and innovative products to address the unique needs of cats. SENVELGO^® oral solution can help pet owners and their diabetic cats continue to enjoy a normal life, despite this chronic disease."

SENVELGO^® oral solution will be available in veterinary clinics in the U.S. by mid-October. The company plans to launch SENVELGO^® oral solution in countries around the world, pending regulatory approvals. 

References

¹ Susan Gottlieb & Jacquie Rand (2018) Managing feline diabetes: current perspectives, Veterinary Medicine: Research and Reports, 9:, 33-42, DOI: 10.2147/VMRR.S125619
² Niessen SJM et al., The Big Pet Diabetes Survey: Perceived Frequency and Triggers for Euthanasia. Vet Sci. 2017 May 14;4(2):27.
³ Data on File at Boehringer Ingelheim
⁴ Zimmering et al., Ease of Use of Semintra ? Cat Owner Feedback Under European Field Conditions ('Easy Programme'), Clinical/research abstracts accepted for presentation at ISFM Congress 2014. Journal of Feline Medicine and Surgery. 2014;16(9):764-769. doi:10.1177/1098612X14545295
⁵ Taylor S, Caney S, Bessant C, Gunn-Moore D. Online survey of owners' experiences of medicating their cats at home. J Feline Med Surg. 2022 Dec;24(12):1283-1293

About SENVELGO^® (velagliflozin oral solution)
SENVELGO^® oral solution is a highly selective inhibitor of the sodium glucose co-transporter 2 (SGLT2). SENVELGO^® promotes removal of glucose via the urine by inhibiting the reabsorption of glucose back into the bloodstream. This rapidly helps to reduce blood glucose to normal and sustained levels. The potential to reverse glucose toxicity can lead to resolution of clinical signs associated with feline diabetes.

This innovative therapeutic solution is indicated to improve glycemic control in cats with diabetes mellitus not previously treated with insulin. The drug is only available with a prescription from a veterinarian.

SENVELGO^® oral solution Important Safety Information
SENVELGO^® (velagliflozin oral solution) is indicated to improve glycemic control in otherwise healthy cats with diabetes mellitus not previously treated with insulin. Before using this product, it is important to read the entire product insert, including the boxed warning. 

Cats treated with SENVELGO may be at an increased risk of diabetic ketoacidosis or euglycemic diabetic ketoacidosis, both of which may result in death. Development of these conditions should be treated promptly, including discontinuation of SENVELGO and initiation of insulin therapy. 

Do not use SENVELGO in cats with diabetes mellitus who have previously been treated with insulin, who are receiving insulin, or in cats with insulin-dependent diabetes mellitus. The use of SENVELGO in cats with insulin-dependent diabetes mellitus, or the withdrawal of insulin and initiation of SENVELGO, is associated with an increased risk of diabetic ketoacidosis or euglycemic diabetic ketoacidosis and death. 

Sudden onset of hyporexia/anorexia, lethargy, dehydration, or weight loss in cats receiving SENVELGO should prompt immediate discontinuation of SENVELGO and assessment for diabetic ketoacidosis, regardless of blood glucose level. SENVELGO should not be initiated in cats with ketonuria, ketonemia, pancreatitis, anorexia, dehydration, or lethargy at the time of diagnosis of diabetes mellitus, as it may indicate the presence of other concurrent disease and increase the risk of diabetic ketoacidosis. 

Keep SENVELGO in a secure location out of reach of children, dogs, cats, and other animals to avoid accidental ingestion or overdose. For more safety information, click here for full prescribing information or visit SENVELGOClinic.com.

Boehringer Ingelheim Animal Health
Boehringer Ingelheim Animal Health is working on first-in-class innovation for the prediction, prevention, and treatment of diseases in animals. For veterinarians, pet owners, farmers, and governments in more than 150 countries, we offer a large and innovative portfolio of products and services to improve the health and well-being of companion animals and livestock. As a global leader in the animal health industry and as part of family-owned Boehringer Ingelheim, we take a long-term perspective. The lives of animals and humans are interconnected in deep and complex ways. We know that when animals are healthy, humans are healthier too. By using the synergies between our Animal Health and Human Pharma businesses and by delivering value through innovation, we enhance the health and well-being of both. For more information visit: https://www.boehringer-ingelheim.com/animal-health

Boehringer Ingelheim
Boehringer Ingelheim is working on breakthrough therapies that transform lives, today and for generations to come. As a leading research-driven biopharmaceutical company, the company creates value through innovation in areas of high unmet medical need. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term, sustainable perspective. More than 53,000 employees serve over 130 markets in the two business units Human Pharma and Animal Health. Learn more at www.boehringer-ingelheim.com??

Intended Audiences Notice
This press release is issued from our U.S. Animal Health Headquarters in Duluth, Georgia, and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.

SENVELGO^® is registered trademark of Boehringer Ingelheim Vetmedica GmbH.  ©2023 Boehringer Ingelheim Vetmedica GmbH. All rights reserved. US-PET-0660-2023

Media Contact:
Brett Israel
Boehringer Ingelheim Animal Health
Director of PR and Communications, U.S. Pets
[email protected]

More information
www.bi-animalhealth.com

SOURCE Boehringer Ingelheim