CUROSURF (poractant alfa), pulmonary surfactant

NEONATOLOGY - Clarification
Opinions on drugs - Posted on Jan 20 2015

Reason for request

Re-assessment of the improvement in actual benefit

Substantial clinical added value in patients with respiratory distress syndrome due to pulmonary surfactant deficiency

- not breathing spontaneously at birth and requiring immediate intubation,

- breathing spontaneously at birth but not or no longer responding to continuous positive airway pressure (CPAP) and requiring intubation for stabilisation.

 

  • CUROSURF has Marketing Authorisation in the treatment of premature infants presenting or at high risk of presenting respiratory distress syndrome (RDS) caused by pulmonary surfactant deficiency (hyaline membrane disease).

 

  •  In light of the available clinical data and recent advances in the management of RDS with antenatal corticosteroid therapy and less invasive routine methods, CUROSURF may be proposed for premature infants:

- breathing spontaneously at birth but no longer responding to CPAP and requiring intubation,
- not breathing spontaneously at birth and requiring intubation.

  • The value of systematic prophylactic treatment with a surfactant is no longer apparent.

 


Clinical Benefit

Substantial

-

Insufficient

Clinical Added Value

important

-