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Recent news about companies that support development of orally inhaled and nasal drug products, including regulatory approvals, new indications for OINDPs, results of clinical studies and additional items. 8 JUNE 2020 Inhalation INDUSTRY NEWS Cipla receives FDA approval for generic Proventil ® HFA Inhalation Aerosol M U M B A I , I N D I A — C i p l a announced it has received final approval for its Abbreviated New Drug Application (ANDA) for Albuterol Sulfate Inhalation Aero- sol 90 mcg (base)/actuation from the United States Food and Drug Administration (FDA). e com- pany noted this is the rst AB-rated generic therapeutic equivalent ver- sion of Merck Sharp & Dohme's Proventil ® HFA Inhalation Aero- sol approved by the FDA. It is also Cipla's rst device-based inhalation product in the market. e prod- uct is used for treatment of acute episodes of bronchospasm or pre- vention of asthmatic symptoms. e company noted it is planning shipments in a staggered manner and "will be donating the product in this time of need." Novartis receives CHMP positive opinion for Enerzair ® Breezhaler ® (QVM149) BA SE L , S W I T Z E R L A N D — Nova r t i s a n nou nc ed t h at t he Europea n Medicines A genc y's (EM A) Committee for Medic- ina l Product s for Hu ma n Use (C H M P) h a s a dopte d a p osi- tive opinion recommending the approval of Enerzair ® Breezhaler ® (QVM149; indacaterol acetate, g lyc opy rron iu m brom ide a nd mometasone furoate [IND/GLY/ M F ]) a s a ma i ntena nc e t re at- ment of asthma in adult patients not adequately controlled with a maintenance combination of a long- acting beta 2 agonist (LABA) a nd a hig h dose of a n in ha led corticosteroid (ICS) who expe- r i e nc e d on e or m or e a s t h m a exacerbations in the previous year. It will be administered using the dose-con rming Breezhaler device, which enables once-daily inha- lation using a single inhaler. The company noted that, if approved, it will be the rst once-daily LABA/ long- acting muscarinic antagonist (LAMA)/ICS fixed- dose combi- nation for patients whose asthma is uncontrolled with LABA/ICS standard-of-care treatment in the EU. It will also be the rst asthma treatment in the EU that can be prescribed together with a digital companion; a Propeller Health sen- sor and app custom-built for the Breezhaler device. e decision was supported by safety and efficacy data from more than 3,000 patients with asthma in the Phase III IRID- IUM study, in which once-daily IND/GLY/MF demonstrated sta- tistically signi cant improvements in lung function compared with once-daily IND/MF (QMF149). Verona Pharma reports positive data with ensifentrine for COPD LONDON, UNITED KING- DOM—Intrado reported that Verona Pharma announced posi- tive e cacy and safety data with a single dose of pressurized metered continued on page 25 W E M A K E T H E W O R L D H E A L T H I E R O N E B R E A T H A T A T I M E G E N E R I C & C U S T O M I S E D w w w . m e r x i n . c o m i n f o @ m e r x i n . c o m M R X 0 0 6 i s a m u l t i c a v i t y m u l t i d o s e d r y p o w d e r i n h a l e r ( D P I ) . M R X 0 0 6 i s b a s e d o n t h e o p e n - i n h a l e - c l o s e p r i n c i p l e . I t i s s u i t a b l e a s a n A B - r a t e d s u b s t i t u t a b l e d e v i c e f o r t r i p l e t h e r a p y c o m b i n a t i o n s : v i l a n t e r o l , u m e c l i d i n i u m , f l u t i c a s o n e .

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