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BRIEF-Prometic announces positive long term clinical data on Ryplazy in plasminogen congenital deficiency
July 11, 2017 / 11:03 AM / 2 months ago

BRIEF-Prometic announces positive long term clinical data on Ryplazy in plasminogen congenital deficiency

July 11 (Reuters) - Prometic Life Sciences Inc

* Prometic announces positive long term clinical data on Ryplazym™ in plasminogen congenital deficiency and provides regulatory update

* Prometic Life Sciences Inc - ‍RYPLAZYM (plasminogen iv) long-term treatment shown to prevent recurrence of lesions at 48 weeks​

* Prometic Life Sciences - ‍FDA inspection of ryplazym(TM) manufacturing facility, as part of ongoing bla evaluation, currently scheduled for summer 2017​

* Prometic Life Sciences Inc - ‍ryplazym (plasminogen iv) maintains same safety, tolerability profile without any serious adverse events at 48 weeks​

* Prometic - ‍48-week clinical data will be submitted as a supplement to bla filing, after ryplazym gets its expected accelerated approval in q4 of 2017​

* Prometic Life Sciences Inc - ‍there was no recurrence of lesions and no safety or tolerability issues observed related to longer-term dosing in study​

* Prometic Life Sciences - responding diligently to all fda requests which to date are not related to underlying clinical data for ryplazym​

* Prometic Life Sciences-in talks with european medicines agency regarding clinical information required to secure regulatory approval of ryplazym in europe Source text for Eikon: Further company coverage:

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