Register Now
Why register?
 The leading web portal for pharmacy resources, news, education and careers November 21, 2017
Pharmacy Choice - Pharmaceutical News - Spiriva Respimat Approval Expanded to Treat Pediatric Asthma - November 21, 2017

Pharmacy News Article

 2/16/17 - Spiriva Respimat Approval Expanded to Treat Pediatric Asthma

TheUSFDA has expanded the use of Spiriva Respimatfor the long-term, once-daily maintenance treatment of asthma for pediatric patients age 6-11, which means the therapy is approved for use in people age 6 and older, according to Boehringer Ingelheim Pharmaceuticals Inc.

The FDA approved the Supplemental New Drug Application (sNDA) under a priority review designation, and the FDA also granted pediatric exclusivity to Spiriva Respimatin light of the clinical trials conducted by Boehringer Ingelheim.

This FDA approval is based on efficacy and safety data from the Phase II and Phase III UniTinA-asthmaclinical development program, which included more than 150 sites globally with over 6,000 patients, including 804 children (aged 6-11 years). The trialdemonstrated proven efficacy and safety for patients age 6 and older.

It is important for healthcare providers to identify and treat patients who may be taking a controller medicine, but who continue to experience uncontrolled asthma symptoms that can make it difficult to breathe and may even cause an exacerbation, said Bradley E. Chipps, MD, Capital Allergy & Respiratory Disease Center, Sacramento, California. As healthcare providers, we need options, like Spiriva Respimat, to consider as an add-on treatment to improve asthma symptoms for the broad age range of patients who may need more control.

Spiriva Respimat, which is delivered as 2 puffs once a day of 1.25 mcg per puff, is part of a class of medicines called long-acting muscarinic antagonist (LAMA) and is the only one of its kind approved for asthma. Spiriva Respimatwas approved in September 2015 for the long-term, once-daily, prescription maintenance treatment of asthma in people age 12 and older. In the treatment of asthma, the maximum benefits in breathing may take up to 4 to 8 weeks.

This FDA approval expands the indication of Spiriva Respimatto a broad range of people, including children, adolescents and adults who may be experiencing uncontrolled asthma, said Sabine Luik MD, Senior Vice President, Medicine & Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. For nearly a century, Boehringer Ingelheim has been focused on addressing serious unmet needs. This approval is further evidence of our ongoing commitment to improving the lives of the patients we serve.

Copyright © 2017 Allied Media. All rights reserved.

Pharmacy News Index
  Drug Delivery Systems
  FDA Final Approvals
  Front Page Healthcare News
  Generic Drugs
  Hospital Industry
  Internet Pharmacy
  IT in Healthcare
  Medicare & Medicaid
  Over-the-Counter Drugs
  Pharm Industry Trends and Policy
  Pharmaceutical Development
  Pharmaceutical Industry


Last Chance
Nov 21: Standards of Practice for Filling Controlled Substance Prescriptions in Florida
Last Chance
Nov 22: Medical Marijuana: Examining the Science, Not the Politics
Nov 27: Drug Diversion and the Law: Updates and Considerations
Nov 28: An Integrative Approach to Managing Arthritis
Nov 29: Influenza 2017-2018: An Update on Prevention and Treatment
Click for entire Webinar Calendar

Special Announcement

Free Membership
Enjoy Drug Search, industry newsletters and more...

Nursing Jobs
Are you a nurse looking for a job?

Check out the Nursing Job Source.

Your number one choice for nursing jobs.

Websites »
Copyright © 2017 Pharmacy Choice - All rights reserved.
Terms and Conditions | Privacy Statement