HERTFORDSHIRE, England, and
PITTSBURGH, May 18, 2019 /PRNewswire/ -- Global
pharmaceutical company Mylan N.V. (NASDAQ: MYL) today
announced four scientific abstracts from the Wixela™ Inhub™
(fluticasone propionate and salmeterol inhalation powder, USP)
development program that will be presented at the 2019 American
Thoracic Society (ATS) International Conference in Dallas, May 17 –
May 22. The data, available for the
first time publicly, further supports the U.S. Food and Drug
Administration's approval in January
2019 of Mylan's Abbreviated New Drug Application for Wixela
Inhub, which is indicated for certain patients with asthma or
chronic obstructive pulmonary disease (COPD).
Mylan President Rajiv Malik commented, "We are extremely
proud to present for the first time publicly our rigorous data
package that demonstrated therapeutic equivalence between Wixela
Inhub and Advair Diskus®. The four studies being presented describe
the pulmonary and systemic bioequivalence between the two products,
device usability that enabled substitutability, and product and
device robustness. The American Thoracic Society International
Conference is the perfect forum to share with this important
medical community the strong science that supported the
introduction of the first FDA-approved therapeutically equivalent,
substitutable generic of Advair Diskus®."
Mylan's data will be presented during the following poster
sessions at the meeting.
- Abstract 11902: Pulmonary Therapeutic Bioequivalence
of Wixela™ Inhub™ and Advair Diskus® in Adults With Asthma
-
- May 19, 11:15 a.m. to 1 p.m.
CT
- Poster Session A64 - Clinical Asthma: Assessment and
Treatment
- Poster #786
- Abstract 12321: Usability and Robustness of the
Wixela™ Inhub™ Dry Powder Inhaler
-
- May 19, 11:15 a.m. to 1 p.m.
CT
- Thematic Poster Session A64 - Clinical Asthma: Assessment and
Treatment
- Abstract 8715: Wixela™ Inhub™ Dry Powder Inhaler: In Vitro
Performance Compared with Advair Diskus® and Inhalation Profiles in
Patients with Asthma or Chronic Obstructive Pulmonary
Disease
-
- May 19, 11:15 a.m. to 1 p.m.
CT
- Thematic Poster Session A64 - Clinical Asthma: Assessment and
Treatment
- Poster #788
- Abstract 12048: Equivalent Systemic Exposure to
Fluticasone Propionate/Salmeterol Following Single Inhaled Doses of
Advair Diskus® and Wixela™ Inhub™: Results of 3 Pharmacokinetic
Equivalence Studies
-
- May 19, 11:15 a.m. to 1 p.m.
CT
- Thematic Poster Session A64 - Clinical Asthma: Assessment and
Treatment
- Poster #789
Full session details for the 2019 Scientific Sessions can be
found at ATS website at conference.thoracic.org.
About Wixela Inhub
Wixela Inhub is indicated for the
twice-daily treatment of asthma in patients age 4 and older not
adequately controlled on long-term asthma medications or whose
disease warrants initiation of treatment with both inhaled
corticosteroids and long-acting beta agonists; maintenance
treatment of COPD; and the reduction of COPD exacerbations in
patients with a history of exacerbations. It is not indicated for
the relief of acute bronchospasm. Wixela Inhub is available in the
100 mcg/50 mcg, 250 mcg/50 mcg and 500 mcg/50 mcg strengths for
asthma patients and the 250 mcg/50 mcg strength for COPD
patients.
About Mylan
Mylan is a global pharmaceutical company
committed to setting new standards in healthcare. Working together
around the world to provide 7 billion people access to high quality
medicine, we innovate to satisfy unmet needs; make reliability and
service excellence a habit; do what's right, not what's easy; and
impact the future through passionate global leadership. We offer a
growing portfolio of more than 7,500 marketed products around the
world, including antiretroviral therapies on which more than 40% of
people being treated for HIV/AIDS globally depend. We market our
products in more than 165 countries and territories. We are one of
the world's largest producers of active pharmaceutical ingredients.
Every member of our approximately 35,000-strong workforce is
dedicated to creating better health for a better world, one person
at a time. Learn more at Mylan.com. We routinely post information
that may be important to investors on our website at
investor.mylan.com.
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SOURCE Mylan N.V.