On 25 June 2020, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Gencebok, intended for the treatment of primary apnoea of premature newborns. The applicant for this medicinal product is Gennisium Pharma.
Gencebok will be available as 10 mg/ml solution for infusion. The active substance of Gencebok is caffeine citrate, a xanthine derivative (ATC code: N06BC01) which acts through the adenosine receptors as a respiratory stimulant.
The benefits with Gencebok are its ability to decrease the frequency of apnoeic episodes, increase respiratory rate and blood pH, decrease pCO2, and improve the function of the respiratory muscles in premature infants with recurrent apnoea. The most common side effects are related to central nervous system stimulation and include irritability, tachycardia and hypertension.
Studies have demonstrated the satisfactory quality of Gencebok. Since Gencebok is administered intravenously and is 100% bioavailable, a bioequivalence (BE) study versus the reference product Peyona was not required. As the maintenance dose can be given by mouth and the strength of Gencebok is different from that of Peyona, the company also provided justification for not performing a BE study in this context, which was considered acceptable.
The full indication is:
Treatment of primary apnoea of premature newborns.
Gencebok should be prescribed by physicians experienced in neonatal intensive care.
Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.
1Hybrid applications rely in part on the results of pre-clinical tests and clinical trials for a reference product and in part on new data.
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