FM December 2020 digital P

phenylalanine. It is widely
used as a spice or flavouring
material for food. It activates
PPARa, which enhances
production of transcription
factor EB (TFEB). TFEB then
binds to the promoter of
genes involved in lysosome
biogenesis and activates their
production. PLX-300 also has
additional activities, such as
reducing inflammation and
preventing apoptosis.
EMA panel
recommends
dolutegravir
to treat HIV
in children
ViiV Healthcare announced
that the Committee for
Medicinal Products for Human
Use (CHMP) of the European
Medicines Agency (EMA) has
issued a positive opinion
recommending marketing
authorisation for dolutegravir
(Tivicay) 5mg dispersible
tablets, which are used in
combination with other
antiretroviral agents for the
treatment of HIV-1 infection in
paediatric patients (treatmentnaïve
or -experienced but
INSTI- naïve) aged at least four
weeks and weighing at least
3kg.
The CHMP positive
opinion includes updated
dosing recommendations,
for dolutegravir film-coated
tablets (10mg, 25mg and
50mg) for children 6 years and
older and weighing at least
14kg, bringing these in line
with the WHO weight bands.
The CHMP’s positive
opinion is based on data
from the ongoing P1093 and
ODYSSEY (PENTA20) studies,
which are being conducted in
collaboration with international
paediatric research networks,
IMPAACT and PENTA-ID. Earlier
this year, the dispersible-tablet
formulation of dolutegravir
was approved.
Baloxavir to treat
influenza in Europe
Roche announced that the European
Medicines Agency’s (EMA) Committee for
Medicinal Products for Human Use (CHMP)
has recommended the approval of baloxavir
marboxil (Xofluza) for the treatment of
uncomplicated influenza in patients aged 12
years and above.
In addition, baloxavir has been
recommended for approval as a preventive
treatment (post-exposure prophylaxis) of
influenza in individuals aged 12 years and
above.
The CHMP recommendation is based
on the results of the phase III CAPSTONE-1,
CAPSTONE-2 and BLOCKSTONE studies.
CAPSTONE-1 was a phase III multicentre,
randomised, double-blind, placebocontrolled
study that evaluated the efficacy
and safety of baloxavir in 1,436 individuals
aged 12 and above in the US and Japan. The
primary endpoint of the study was time to
alleviation of symptoms. The study found the
following results:
The drug met its primary endpoint
compared to placebo: Significantly reduced
the duration of influenza symptoms by more
than one day (median time 53.7 hours versus
80.2 hours; p