NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

That’s a common misconception, IMO
MHRA does not only refer applications to CHM when they are “uncomfortable”.
In practice, many new active substances (especially first-in-class, biologics, or novel mechanisms) are routinely considered by CHM as part of the national procedure — even when approval is straightforward.
A very recent example is depemokimab (Exdensur) for eosinophilic asthma and CRSwNP:
- Discussed at the CHM meeting in October 2025
- CHM minutes published before formal approval
- MHRA approval followed in December 2025 without controversy
So CHM involvement does not imply regulator discomfort — it often reflects scientific novelty, public health relevance, or statutory routing under UK law.

SUMMARY OF THE COMMISSION ON HUMAN MEDICINES MEETING HELD ON
THURSDAY 30TH OCTOBER 2025

LICENSING

NEW DRUGS (not previously licensed in the United Kingdom)
The Commission considered and advised on a medicine used as an add-on treatment to
standard therapies for the maintenance treatment of eosinophilic asthma (a specific type of
asthma where the inflammation in the airways is caused by high levels of a particular white
blood cell called an eosinophil) and for treatment of chronic rhino sinusitis with nasal polyps
(a long-term medical condition where the lining of the nose and sinuses are constantly
inflamed and this inflammation leads to the formation of soft, non-cancerous growths called
polyps)

.
https://app.box.com/s/jv487awvqzzsrdql0o34h9gg350ceyd4/file/2073365630019

Press release

UK approves the first twice yearly biological medicine for asthma and severe chronic rhinosinusitis with nasal polyps
As with any medicine, the MHRA will keep the safety and effectiveness of depemokimab under close review.

From:
Medicines and Healthcare products Regulatory Agency
Published
15 December 2025

https://www.gov.uk/government/news/uk-approves-the-first-twice-yearly-biological-medicine-for-asthma-and-severe-chronic-rhinosinusitis-with-nasal-polyps