Date: 2016-12-13
Type of information: Granting of a Market Authorisation in the EU
Product name: Rekovelle®
Compound: follitropin delta
Therapeutic area: Women health - Fertility
Action mechanism: hormone. Follitropin delta (also known as FE 999049) is the first recombinant follicle stimulating hormone (rFSH) derived from a human cell line (PER.C6® cell line). It has been developed for individualised dosing based on a woman’s serum anti-Müllerian hormone (AMH) level, as determined by a companion diagnostic, the Elecsys® AMH Plus immunoassay from Roche, and her body weight. Follitropin delta is structurally and biochemically distinct from other existing recombinant FSH treatments.
Company:
Disease:
Latest news: * On December 13, 2016, Ferring Pharmaceuticals announced that the European Commission (EC) has granted marketing authorisation for Rekovelle® (follitropin delta), a human recombinant follicle stimulating hormone (human rFSH), for use in controlled ovarian stimulation for the development of multiple follicles in women undergoing assisted reproductive technologies (ART), such as an in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycle. Rekovelle® is the first rFSH to be derived from a human cell line and is the first rFSH treatment to be administered with an individualised dosing regimen. Rekovelle®’s individualised dosing regimen is based on a woman’s serum anti-Müllerian hormone (AMH) level and her body weight. With these parameters, a specific daily dose of Rekovelle® is determined for each patient from the start of the ART cycle.1-4,6,7 AMH has surfaced as one of the most reliable biomarkers for assessing ovarian reserve.It can help predict a woman’s ovarian response to gonadotrophin stimulation and can also help guide the dosing of fertility treatments.8,9 AMH will be measured by a companion diagnostic, the Elecsys® AMH Plus immunoassay from F. Hoffmann-La Roche Ltd (Roche).6,7 The EC approval of Rekovelle® is based on a comprehensive clinical data package, including results from the Phase 3 ESTHER trials (Evidence-based Stimulation Trial with Human rFSH in Europe and Rest of World).2-4 Results of the ESTHER-1 trial were accepted for publication in Fertility & Sterility (article in press and available early online). The data shows that individualised treatment with Rekovelle® (follitropin delta), as compared to treatment with conventional rFSH (follitropin alfa), had similar results for the co-primary endpoints of ongoing pregnancy rates and ongoing implantation rates. Patients receiving Rekovelle® also reached the optimum oocyte yield (8–14 oocytes) more often than those receiving conventional rFSH treatment, with fewer clinically-relevant instances of poor and excessive ovarian response. In addition, ovarian hyperstimulation syndrome (OHSS) and/or OHSS preventive interventions occurred less frequently (p<0.05) in women receiving Rekovelle®than women receiving conventional rFSH treatment.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization:
UE authorization: 2016-12-13
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
