Follitropin
delta (Rekovelle, Ferring Pharmaceuticals A/S) is a novel human
recombinant follicle-stimulating hormone (rhFSH) indicated for use in controlled
ovarian stimulation (COS) in women undergoing assisted reproductive technology
(ART) therapy such as in vitro fertilization (IVF) or intracytoplasmic sperm injection
(ICSI).
Follitropin
delta is available as solution for injection (12 µg/0.36 ml, 36 µg/1.08 ml
and 72 µg/2.16 ml) It is a recombinant human follicle-stimulating hormone (FSH)
belonging to the pharmacotherapeutic class of gonadotropins (ATC code:
G03GA10). The amino acid sequences of the two FSH subunits in follitropin delta
are identical to the endogenous human FSH sequences.[1]
It
can be administered as tailored regimen to each individual patient based on the
measurement of the woman’s serum anti-Müllerian hormone (AMH) and Body Mass
Index (BMI).
Personalized
treatment is a novel approach to the management of patients undergoing Assisted
Reproductive Techniques (ARTs), with the ultimate goal of helping couples to
conceive in an efficient and safe manner.
The
approval comes in wake of results of Phase III (Evidence-based Stimulation Trial
with Human rFSH in Europe and Rest of
World) (ESTHER) trials of follitropin delta for pregnancy-related complexities
which was presented at the 32nd Annual Meeting of the European
Society of Human Reproduction and Embryology (ESHRE) in Helsinki, Finland.[2]
ESTHER-1
is a multicentric, randomized, assessor-blind, controlled trial conducted in
Europe and other centers in the world. The study involved 1,326 patients from
37 fertility clinics in 11 countries between ages 18 to 40 undergoing their
first cycle of in-vitro fertilization (IVF) or intracytoplasmic injection
(ICSI).[3]
Patients
were administered with an individualized dosing regimen of follitropin delta which
was fixed throughout stimulation compared with daily follitropin alfa dose of
150 IU (11 µg) for the first five days, (conventional dosing regimen) which was
open to dose adjustments after five days.
The
number of oocytes retrieved and blastocysts obtained were similar for both the
arms of the trial (10.0 and 10.4).
More patients
using the individualized regimen of Folliotropin delta obtained the target
oocytes number of 8-14 as compared to using conventional regimen. (p<0.05).
The study arm also has less incidences of OHSS (p<0.05).
The
ongoing pregnancy as well as well as ongoing implantation rates were also similar
in both the groups.
Data
from the ESTHER-2 trial in which a subset of women underwent additional
assessor-blind stimulation cycles (a total of 513 in cycle 2, and 188 in cycle
showed no increased immunogenicity risk.[4]
The
most common side effects are ovarian hyperstimulation syndrome (OHSS), headache,
nausea, fatigue pelvic discomfort and pelvic or adnexal pain,
[1] http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/003994/WC500214216.pdf
[2] Nyboe
Andersen A and Arce JC on behalf of the ESTHER-1 trial group. Efficacy and
safety of follitropin delta in an individualised dosing regimen: A randomised,
assessor-blind, controlled phase 3 trial in IVF/ICSI patients (ESTHER-1).
Poster presented at 32nd Annual Meeting of the European Society of Human
Reproduction and Embryology (ESHRE) in Helsinki, 3–6 July 2016.
[3] ESTHER-1
trial. www.clintrials.gov Available at: https://clinicaltrials.gov/ct2/show/NCT01956110. Last
accessed: October 2016
[4] ESTHER-2
trial. www.clintrials.gov. Available at: https://clinicaltrials.gov/ct2/show/NCT01956123. Last
accessed: October 2016
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