Research and Markets: Glaxo-Smith Kline and Theravance's Relovair: Will it be a breath of fresh air or are there regulatory hurdles ahead?
Research and Markets (http://www.researchandmarkets.com/research/47jdbq/glaxosmith_kline) has announced the addition of the "Glaxo-Smith Kline and Theravance's Relovair: Will it be a breath of fresh air or are there regulatory hurdles ahead?" report to their offering.
Relovair combines vilanterol, a novel long-acting beta agonist (LABA), and fluticasone furorate, an inhaled corticosteroid (ICS). Both components are analogs respectively of salmeterol and fluticasone propionate, the components of Advair. But unlike Advair, Relovair is suitable for once-daily dosing. The sponsors have completed extensive phase II trials with each component, but the future of those monotherapy programs is uncertain. They have also completed one phase II trial in COPD with the combination (Relovair) and have moved the program into phase III in asthma and COPD. The asthma trials target ex-US filings, whereas the COPD trials will support Relovair's initial entry into the US market.
Specific to vilanterol (monotherapy) and more broadly to Relovair, LABA safety has been the focus of ongoing regulatory concern and FDA's positions are still evolving. This report explores that history in detail, looking at the nuanced implications for Relovair and the associated programs. It also reviews the likelihood of success in phase III, the competitive landscape and prospects for Relovair's market success.
Key Topics Covered:
1. Chronic obstructive pulmonary disease (COPD) and asthma
2. Current treatments
1. Phase I healthy-volunteer studies explored vilanterol kinetics and effects
2. COPD trials lent insight into vilanterol kinetics, activity, and safety
3. Vilanterol asthma trials parallel the COPD trials in design and outcomes
4. GSK has conducted many large asthma trials with fluticasone furorate
5. Phase II Relovair COPD trial
6. Phase III Relovair trials
CLINICAL AND REGULATORY DISCUSSION
1. Does the Relovair COPD program meet FDA standards?
- COPD indications and their endpoints
- Dose finding
- Are Relovair COPD pivotal trials adequate in duration and number?
- Other design considerations in the FDA guidance
2. What about the adequacy of the asthma program?
3. Combination products add special challenges
4. LABA-related safety issues may create stumbling blocks
- Early historical background
- Subsequent FDA Advisory Panels
- FDA's February 18, 2010 release
- What about COPD?
5. Cardiovascular safety as a separate issue
6. What does this all mean for GSK's programs?
1. Market overview
2. At first, competition may come from GSK itself, but Spiriva is also key
3. The respiratory pipeline is unusually robust
- GSK's and Theravance's pipeline behind these programs is also robust
- Novartis's pipeline may also compete directly with Relovair
- Merck's Dulera
- Several other long-acting ß agonists are in the pipeline
- Other advanced pipeline products
For more information visit http://www.researchandmarkets.com/research/47jdbq/glaxosmith_kline