Kamada's Plans For Emphysema Drug Delayed By Years After MAA Withdrawal
Kamada has withdrawn its European approval application for an inhaled version of its emphysema drug Glassia – a move that shocked investors because of the company's continued insistence data from a failed pivotal study would be enough to convince regulators.
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Kamada of Israel believes that despite missing the primary endpoint in a Phase II/III trial, positive secondary endpoint data and results from a recently initiated US Phase II trial will be enough to persuade regulators to approve its inhaled alpha-1 antitrypsin (AAT) therapy for the treatment of alpha-1 antitrypsin deficiency (AATD or inherited emphysema).
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