Issue link: https://www.e-digitaleditions.com/i/1056686
Recent news items on companies that develop, manufacture and provide products and services that support development of orally inhaled and nasal drug products. 8 December 2018 Inhalation Industry news FDA approves Stiolto ® Respimat ® for COPD exacerbation reduction RIDGEFIELD, CONNECTI- CUT—According to PRNewswire, Boehringer Ingelheim announced t h a t t h e U S F o o d a n d D r u g Administration (FDA) approved a Supplemental New Drug Applica- tion (sNDA) and new labeling for Stiolto ® Respimat ® (tiotropium bromide and olodaterol) Inhala- tion Spray that includes data show- ing a meaningful reduction in chronic obstructive pulmonary disease (COPD) exacerbations, driven by tiotropium. Boehringer I n g e l h e i m n o t e d t h a t S t i o l t o Respimat is the first in its class to have exacerbation data included in the product labeling. e FDA also revised the indication for Stiolto Respimat, which is now approved for the treatment of patients with COPD, including chronic bron- chitis and emphysema. Previously, the Stiolto Respimat indication was for the treatment of airflow limitation in patients with COPD, including chronic bronchitis and emphysema. e Stiolto Respimat label will be updated to include clinical trial data for Spiriva ® Respimat that shows a decrease in exacerbations, as well as data from the DYNAGITO ® trial, a 52-week study involving more than 7,800 people across a broad range of patients with COPD, comparing S t i o l t o R e s p i m a t t o S p i r i v a Respimat in the reduction of COPD exacerbations. European Commission expands label of GSK/ Innoviva's COPD inhaler B R E N T F O R D , U N I T E D K I N G D O M — P h a r m a T i m e s Online reported that the European Commission expanded the label of G l a x o S m i t h K l i n e / I n n o v i v a ' s once-daily Trelegy™ Ellipta ® (fluti- casone furoate, umeclidinium and vilanterol; FF/UMEC/VI), noting the label change makes Trelegy Ellipta the first single-inhaler, tri- ple therapy indicated for mainte- nance of patients with moderate to severe chronic obstructive pulmo- nary disease (COPD) not ade- quately treated with dual broncho- dilation or with an inhaled cortico- steroid (ICS) and a long-acting beta-agonist (LABA). e update w a s b a s e d o n d a t a f r o m t h e InforMing the PAthway of COPD Treatment (IMPACT) study, which showed Trelegy Ellipta (FF/ UMEC/VI) was superior to both the ICS/LABA Relvar ® /Breo ® Ellipta (FF/VI) and the long-act- ing muscarinic receptor antagonist (LAMA)/LABA Anoro ® Ellipta (UMEC/VI) in patients with mod- erate to severe COPD. e study had multiple, clinically important endpoints, including reducing exacerbations and improving lung function and health-related quality of life. Trelegy Ellipta was origi- nally approved in the European Union in November 2017 as a maintenance treatment in adult patients with moderate to severe COPD who are not adequately treated by a combination of an ICS and a LABA. Vectura and Hikma will develop generic versions of GSK's Ellipta ® portfolio C H I P P E N H A M , U N I T E D KINGDOM—Vectura Group has announced an agreement with Hikma Pharmaceuticals for the global development and commer- cialization of generic versions of GSK's Ellipta ® portfolio, utilizing Vectura's proprietary Open-In- hale-Close dry powder inhaler. F o l l o w i n g i n t e r a c t i o n s w i t h United States Food and Drug A d m i n i s t r a t i o n ( F D A ) , t h e Open-Inhale-Close dry powder inhaler device has the potential to be developed as an AB-rated sub- stitutable drug/device combina- tion for generic versions of the GSK Ellipta ® portfolio. e pro- g r a m i n c l u d e s d e v e l o p m e n t generics of up to five GSK respira- t o r y m e d i c i n e s . V e c t u r a a n d Hikma have agreed to develop and commercialize at least three products. A substitutable generic Vicki L. Schuman Editor, Inhalation A LETTER FROM THE EDITOR Welcome to the December 2018 issue, which we believe contains multiple articles you will find useful. e issue focus of quality/compli- ance is addressed in the second arti- cle in a two-part series about USP general chapter development for OINDPs, as well as in an article on spray-dried dry powders for 505(b) (2) drug product development. e Back Page article describes the new pediatric yardstick. e cross-indus- try organizations update is from ISAM and the issue includes a pre- view of Drug Delivery Partnerships 2019. In addition, we spotlight our advertisers and the products and services they provide. is is also my 50th issue as Inhala- tion's editor, which gives me the opportunity to express my grati- tude to so many people. I have been delighted to see the support for Inhalation within the commu- nity. It is my great pleasure to thank our advertisers, authors, edi- torial board members, additional peer reviewers, buyer's resource participants, webinar presenters and guest moderators, cross-indus- try and media partners and more than 3,500 readers. I am also very happy to acknowledge and thank the members of Inhalation's staff. Looking ahead, we are excited to work with you in 2019 and beyond. We wish you the very best for the holiday season and the New Year. With thanks and kind regards, Vicki