Replies to post #743691 on NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

I agree that it is likely referring to AndroFeme® Cream 10mg/ml, a female-specific testosterone formulation. This medication was approved in Australia in 2020 for the management of hypoactive sexual desire dysfunction (HSDD) in postmenopausal women, a condition characterized by a persistent absence of sexual desire associated with personal distress.

In the United Kingdom, a Marketing Authorisation Application (MAA) for AndroFeme® was accepted for assessment by the MHRA on 16th March 2023 under the national procedure. However, due to a backlog in the processing of applications, the review process did not commence as expected.

To accelerate regulatory approval, Lawley Pharmaceuticals submitted a new application on 8th March 2024 via the recently introduced International Recognition Procedure (IRP), leveraging assessments by trusted international regulatory partners. The IRP Recognition B-route provides an expedited review timeline of 110 days, which offers a faster pathway to address the absence of a licensed testosterone treatment for HSDD in the UK.

INTERNATIONAL RECOGNITION PROCEDURE OFFERS HOPE FOR UK’S POSTMENOPAUSAL WOMEN.
Categories: menopause, testosterone for women, hypoactive sexual desire dysfunction HSDD
Posted: March 8, 2024

Hypoactive Sexual Desire Dysfunction (HSDD)

Perth, Australia: Lawley Pharmaceuticals, via UK-based commercial partner, Andro Pharmaceuticals Ltd, today submitted a Marketing Authorisation Application (MAA) for AndroFeme cream (testosterone 10mg/ml) for women via the newly introduced International Recognition Procedure (IRP) for assessment by the UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA).

AndroFeme cream (testosterone 10mg/ml), a female specific testosterone formulation, has been licensed by Australian regulatory authorities since 2020 for the management of HSDD in postmenopausal women.

HSDD is characterised by the loss or absence of sexual desire associated with personal distress which affects between 6-13% of women in Europe. (Ref 1)

In March 2023 the AndroFeme dossier was validated for assessment under the MHRA national procedure, however has yet to progress in the queue due to a back-log of dossiers.

The MHRA IRP timetable for assessment via an IRP Recognition B pathway is 110-days.

When commenting on the 1 January 2024 launch of the IRP, Julian Beach, MHRA Interim Executive Director of Healthcare Quality and Access said:
“IRP allows us to access the expertise of trusted regulatory partners, who have already authorised products. In return, our partners can consider applications based on MHRA authorisations, creating a ‘win-win’ for regulators, developers of innovative treatments, and patients.”

Lawley’s Medical Director, Michael Buckley said “The IRP offers UK postmenopausal women renewed hope that they will soon be able to access to a female-specific formulation which will address the absence of a licensed testosterone treatment for HSDD"

https://www.lawleypharm.com.au/news/international-recognition-procedure-offers-hope-for-uks-postmenopausal-women/