|Sanofi Announces FDA Panel Recommends Approval of Nasacort; Integra Receives FDA Clearance for Titan(TM)|
|By Staff and Wire Reports|
|Wednesday, 31 July 2013 19:43|
Sanofi (NYSE: SNY) announced the U.S. FDA Nonprescription Drugs Advisory Committee (NDAC) voted 10 to 6, with 2 abstentions, recommending approval of Nasacort® AQ Nasal Spray (triamcinolone acetonide) for over-the-counter use in the U.S.
"Today's positive NDAC vote was an important step forward in providing broader access to Nasacort AQ for nasal allergy sufferers," said Charles Hugh-Jones, MD, MRCP, Chief Medical Officer, Sanofi US. "We appreciate the feedback from the Committee and look forward to working with FDA in completing its review."
If approved by the FDA, Nasacort AQ would be first-in-class as an OTC medicine and marketed by Sanofi's consumer healthcare division, Chattem, Inc. The proposed OTC indication is temporary relief of nasal symptoms of hay fever or other upper respiratory allergies (allergic rhinitis) in adults and children 2 years of age and older.
"The OTC availability of Nasacort would continue to build on Chattem's highly successful OTC launch of Allegra and further expand our consumer healthcare offering," said Anne Whitaker, President, North America Pharmaceuticals, Sanofi.
Among prescription and OTC allergy products, Nasacort AQ and other nasal sprays in the same medication class are considered the most effective treatment for hay fever and other upper respiratory allergies.
The NDAC panel's recommendation will be considered by the FDA in its review of the Supplemental New Drug Application (sNDA) for Nasacort AQ as an OTC treatment. The FDA's decision will also be based on data submitted from 13 placebo-controlled efficacy studies, and safety information from 43 clinical studies, as well as information from 16 years of post-marketing surveillance data.
Prescription Indication Nasacort AQ Nasal Spray is indicated for the treatment of the nasal symptoms of seasonal and perennial allergic rhinitis in adults and children 2 years of age and older.
Integra LifeSciences Holdings Corporation (Nasdaq: IART) announced that the Integra® Titan™ Reverse Shoulder System has received 510k clearance from the U.S. Food and Drug Administration (FDA). Integra expects to begin a limited market release in the United States in the third quarter of 2013, and upon CE Mark clearance in Europe, begin a full global commercial launch.
The Reverse Shoulder System is built on a unique platform stem. This platform stem simplifies the conversion of a primary total shoulder, or hemi for fracture, to a reverse shoulder, without the need to remove a stem that is well-fixed in the patient's bone. The system offers fully interchangeable components, which allow all primary, reverse, and fracture humeral bodies to be used with either the press-fit or cemented platform stems. This flexibility provides surgeons with minimally invasive intraoperative options, and the ability to offer continued care for the lifetime of the patient.
William Geissler, M.D., Professor of Orthopaedic Surgery, University of Mississippi Medical Center, said that, "The versatility of the Integra Titan Reverse Shoulder System will allow me to custom fit the prosthesis intraoperatively to the unique anatomy of each of my patients. Additionally, it builds off the same platform-based press-fit stem as the Titan Total Shoulder, which allows for easier conversion, if ever required."
"The Reverse Shoulder System is an exciting addition to Integra's shoulder portfolio, which includes the Total Shoulder System and the Humeral Resurfacing Arthroplasty System" said Robert Paltridge, Integra's President, Extremity Reconstruction. "The patient and surgeon benefits built into our new platform-based system are a true testimony to our continued investment in advancing cost-effective technology in shoulder surgery."
The global shoulder replacement market is estimated to reach approximately $865 million in 2014 and $1.3 billion by 2017. With the addition of the Titan Reverse Shoulder System, which addresses both the press-fit and cemented reverse shoulder market, Integra is well positioned to gain a key foothold in this rapidly growing market.
Integra will offer surgeons hands-on training on the Titan Reverse Shoulder System at the "Clinical Concepts in Shoulder Arthroplasty Course" being held at the Pacific American Life Science Learning Center on August 10, 2013 in San Diego, CA.
Integra LifeSciences, a world leader in medical technology, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care. Integra offers innovative solutions in orthopedic extremity surgery, neurosurgery, spine surgery, and reconstructive and general surgery. For more information, please visit www.integralife.com.
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