SEVEN NEW MEDICINES
RECOMMENDED FOR APPROVAL
EMA’s human medicines committee (CHMP) recommended twelve medicines
for approval at its December 2025 meeting.

The committee recommended
granting a conditional marketing
authorisation for Anktiva
(nogapendekin alfa inbakicept), for
the treatment of adults with a type
of bladder cancer that affects the
lining of the bladder (non-muscle
invasive bladder cancer, NMIBC)
and that is at high risk of growing
and spreading. Bladder cancer is
one of the most common cancers
in the European Union (EU),
affecting over 200,000 people each
year, with most cases being NMIBC.

The CHMP recommended granting
a marketing authorisation for
Aumseqa (aumolertinib), for the
treatment of EGFR-mutated non-
small cell lung cancer.

Exdensur (depemokimab)
received a positive opinion from
the CHMP for the treatment of
a particular type of asthma called
severe eosinophilic asthma, and for
severe chronic rhinosinusitis with
nasal polyps, an inflamed lining of
the nose and sinuses with swellings
in the nose.

The CHMP adopted a positive
opinion for Myqorzo (aficamten)
for the treatment of adults
with obstructive hypertrophic
cardiomyopathy, a disease in which
the muscle in the main pumping
chamber of the heart becomes
thickened or enlarged, which can
block the flow of blood from the
heart to the rest of the body.

The committee recommended
granting a marketing authorisation
for Mnexspike (COVID-19 mRNA
vaccine), for the prevention of
COVID-19 in people from 12 years
of age.

The committee adopted positive
opinions for two biosimilar
medicines: Gotenfia (golimumab), for the
treatment of rheumatoid arthritis,
juvenile idiopathic arthritis, psoriatic
arthritis, axial spondyloarthritis and
ulcerative colitis.

Ranluspec (ranibizumab), for the
treatment of neovascular age-
related macular degeneration, visual
impairment and other retinopathies.

104 NEW MEDICINES RECOMMENDED FOR
APPROVAL; 38 HAD A NEW ACTIVE SUBSTANCE
In 2025, EMA recommended
104 medicines for marketing
authorisation. Of these, 38 had a
new active substance which had
never been authorised in the
EU before.

This includes medicines representing
important innovation or
contribution to public health,
such as the first medicine to treat
non-cystic fibrosis bronchiectasis,
a first-in-class treatment to
delay the onset of stage 3 type 1
diabetes in children and adults, and
the first oral medicine to treat
postpartum depression following
childbirth. EMA also recommended 16
medicines for rare diseases, including
the first medicine to treat Wiskott-
Aldrich syndrome, a rare, inherited
disease of the immune system, that
affects almost exclusively males,
and a disease-modifying gene
therapy applied as a topical gel to
treat wounds in patients of all ages
with a rare condition that makes
the skin very fragile (dystrophic
epidermolysis bullosa).

EMA also adopted three positive
opinions for medicines for use in
countries outside the EU, including
a medicine for pre-exposure
prophylaxis (PrEP) in combination
with safer sex practices to reduce
the risk of sexually acquired
human immunodeficiency virus
type 1 (HIV-1) infection in adults
and adolescents. This medicine
will facilitate PrEP uptake and
compliance because it only has to
be administered twice a year via a
subcutaneous injection.

There were also 41
recommendations for new
biosimilar products. Biosimilars
are interchangeable with reference
products, making them a core
part of the healthcare system for
managing costs and expanding
access to essential treatments.

CHP PACKER INTERNATIONAL update 21