PEDIAPHARM RECEIVES HEALTH CANADA APPROVAL FOR RUPATADINE
Pediapharm Inc. (PDP.V) has received Health Canada’s approval of rupatadine (10-milligram tablet and one-milligram-per-millilitre oral solution) for the relief of the symptoms associated with seasonal allergic rhinitis (SAR), perennial allergic rhinitis (PAR) and chronic spontaneous urticaria (CSU) in patients two years of age and older.
Rupatadine is the first prescription (Rx) antihistamine being launched over the past decade with all 3 indications (SAR, PAR and CSU), including a formulation for children over 2 years of age. It will be launched in the Canadian antihistamine market estimated at $130 million1. Moreover, it will benefit from 8.5 years of market exclusivity granted by Health Canada’s Office of Patented Medicines and Liaison under section C.08.004.1 of the Food and Drug Regulations.
Allergic rhinitis (SAR and PAR) is an inflammatory disease of the nasal mucous membranes and it is one of the most common chronic health conditions with 20 to 25% of Canadians being affected2. Chronic Spontaneous Urticaria (CSU) is a severe and distressing skin condition for which discomfort associated with this disorder can often pose a serious challenge to the treating clinician and a long-term hardship for patients and their families3,4 .
According to Dr. Paul Keith, Associate Professor, Division of Clinical Immunology and Allergy, Department of Medicine, McMaster University ”Allergic Rhinitis and Chronic Urticaria are two conditions that can be challenging to treat. Many available treatments are not always effective or have undesired side effects, potentially leading to patients’ frustration and non-adherence. A new antihistamine with a unique mode of action that could provide additional anti-inflammatory effect as well as rapid and effective relief of patients’ symptoms is more than welcome and will certainly become an excellent addition to any physicians’ treatment arsenal.”
”Rupatadine represents a unique opportunity to introduce innovation in a growing prescription market as many patients and physicians remain unsatisfied with current over-the-counter treatment options,” stated Richard Labelle, Pediapharm’s Vice President of Sales and Marketing. ”Given its strong medical evidence and unique mode of action, rupatadine has the potential to significantly improve the quality of life of many patients suffering from allergies or urticaria.”
Amongst children, first generation of antihistamine are still widely used to treat allergic rhinitis and urticaria but according to Dr. Estelle Simons, Professor in the Department of Pediatrics and Child Health and the Department of Immunology at the University of Manitoba ”Using modern non-sedating, non-impairing H1-antihistamines such as rupatadine is preferable to using old first-generation, potentially sedating and impairing H1-antihistamines.” Dr. Simons also mentioned that “In extensive studies in adults and children with allergic rhinitis or urticaria, rupatadine has been confirmed to reduce symptoms and improve quality of life. It has a rapid onset of action and its efficacy does not decrease over time. It has an excellent safety profile and as importantly, rupatadine does not cause sedation or impairment of brain function.”
”Pediapharm already has a solid infrastructure in place ready to take on new products like rupatadine,” stated Sylvain Chretien, President and CEO of Pediapharm. “The approval of rupatadine is a major milestone for our company and it will have a substantial impact on our future growth. It also demonstrates our ability to obtain Health Canada approval for our pipeline products, which include two other dossiers submitted to Health Canada in the last 8 months.”
Rupatadine is a new second-generation antihistamine and platelet-activating factor (PAF) antagonist discovered and developed by Uriach, and currently available in 62 countries around the world. In addition to Canada, rupatadine is expected to be launched before the end of 2017 in other countries like Korea and Japan among others. The high potency, good efficacy and excellent safety profile of the product have been demonstrated under an extensive clinical development program. Rupatadine (Tablet 10mg and Oral Solution 1mg/mL) is indicated for the treatment of the symptoms associated with Seasonal Allergic Rhinitis (SAR), Perennial Allergic Rhinitis (PAR) and Chronic Spontaneous Urticaria (CSU) in patients 2 years of age and older.