April 23, 2018 / 11:54 AM / a month ago

BRIEF-Kamada Gets Feedback From FDA On Proposed Phase 3 Protocol For Inhaled Alpha-1-Antitrypsin

April 23 (Reuters) - Kamada Ltd:

* KAMADA RECEIVED FEEDBACK FROM FDA ON PROPOSED PHASE 3 PROTOCOL FOR INHALED ALPHA-1-ANTITRYPSIN FOR TREATMENT OF ALPHA-1 ANTITRYPSIN DEFICIENCY DISEASE

* KAMADA LTD - WILL NOT BE ABLE TO INITIATE PHASE 3 CLINICAL STUDY OF INHALED AAT FOR TREATMENT OF AATD IN H2 2018 UNTIL IND IS APPROVED

* KAMADA LTD - CANNOT CURRENTLY ANTICIPATE IF AND WHEN DISCUSSIONS WITH FDA WILL MATERIALIZE INTO AN APPROVED IND

* KAMADA LTD - HAS FORMALLY REQUESTED, EXPECTING TO PRESENT PLANNED PHASE 3 PROTOCOL IN SCIENTIFIC ADVICE MEETING WITH EMA IN Q3 2018

* KAMADA - INTENDS TO PROVIDE INFORMATION REQUESTED BY FDA AND DATA, AS WELL AS IMPLEMENT PROPOSED CHANGES IN STUDY PROTOCOL, DURING Q3 2018

* KAMADA LTD - ANTICIPATES THAT PLANNED RESPONSE WILL RESULT IN CONTINUED INTERACTION WITH FDA

* KAMADA - IN APRIL, FDA ISSUED RESPONSE LETTER PROVIDING FURTHER GUIDANCE, ADDITIONAL QUESTIONS REGARDING PROPOSED PIVOTAL PHASE 3 PROTOCOL,

* KAMADA - PROPOSED MODIFICATIONS, ADDITIONAL INFORMATION TO BE PROVIDED, INTENDED TO MITIGATE CONTINUED SAFETY-RELATED CONCERNS COMMUNICATED BY FDA

* KAMADA LTD - CORRESPONDENCE INDICATED FDA HAS CONTINUED CONCERNS AND QUESTIONS RELATED TO SAFETY PROFILE OF INHALED AAT Source text for Eikon: Further company coverage:

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