Bucelipase alfa

Drug Profile

Bucelipase alfa

Alternative Names: Bile salt stimulated lipase; BSSL; Exinalda; Kiobrina; recombinant human BSSL; rhBSSL

Latest Information Update: 10 Sep 2017

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At a glance

  • Originator AstraZeneca
  • Developer Swedish Orphan Biovitrum
  • Class
  • Mechanism of Action Lipase replacements
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Malabsorption syndromes
  • New Molecular Entity Yes

Highest Development Phases

  • Discontinued Malabsorption syndromes

Most Recent Events

  • 02 Nov 2014 Swedish Orphan Biovitrum terminates phase III trial in Malabsorption disorders (In neonates) in Belgium, Czech Republic, Denmark, France, Germany, Hungary, Italy, Poland, Russia, Spain, Sweden and the United Kingdom (NCT01413581)
  • 27 Mar 2014 Top line adverse events and efficacy data from the phase III LAIF trial in Malabsorption disorders (in preterm neonates) released by Swedish Orphan Biovitrum
  • 05 Aug 2013 Swedish Orphan Biovitrum completes enrolment in the LAIF phase III trial for Malabsorption disorders in preterm neonates in Belgium, Czech Republic, Denmark, France, Germany, Hungary, Italy, Poland, Russia, Spain, Sweden and the United Kingdom (NCT01413581 / EudraCT2010-023909-35)
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