ARIKACE to Receive Orphan Medicinal Product Designation in the European Union to Treat Lung Infections Caused by Nontuberculous Mycobacteria
MONMOUTH JUNCTION, NJ -- (Marketwired) -- 02/10/14 -- Insmed Incorporated (NASDAQ: INSM), a biopharmaceutical company focused on developing an inhaled anti-infective to treat patients battling serious lung diseases in orphan indications that are often life-threatening, today announced that the Committee for Orphan Medicinal Products of the European Medicines Agency (EMA) has issued a positive opinion on the Company's application for orphan designation for ARIKACE®, the Company's liposomal amikacin for inhalation, for the treatment of lung disease caused by nontuberculous mycobacteria (NTM). Orphan drug designation in the European Union (EU) is given to products that are designed for the diagnosis, prevention or treatment of rare diseases that are life-threatening or chronically debilitating.
Odd about some of the dates. So, what does the European Commission really do?
"Having regard to the favourable opinion of the European Medicines Agency, drawn up
on 6 February 2014 by the Committee for Orphan Medicinal Products and received by
the Commission on 27 February 2014,"
Thanks Edge - reminder of the earlier clue regarding anticipated timeline:
"Beerse, Belgium, (March 06, 2014) - Janssen-Cilag International NV (Janssen) announced today that the European Commission (EC) has granted conditional approval to SIRTURO® (bedaquiline) in the European Union, for use as part of an appropriate combination regimen for pulmonary multi-drug resistant tuberculosis (MDR-TB) in adult patients, when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability.
The decision from the EC follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending the approval of bedaquiline on December 20, 2013."
I guess I need to point out that a positive opinion on Orphan designation is not a positive opinion on whether or not whether or not the EMA should approve Arikace on the basis of Insmed's anticipated filing for approval in H2.
Would imagine the filing will go to the CHMP - which will in due course make its recommendation - followed hopefully by EMA approval three months later.
If anybody here fancies sharing the load, the timeline could be firmed up with a a recent example or two of the time from the filing for approval to the time the CHMP announces its decision.