Women’s Health Video Recap—February 4, 2026

This biweekly Women’s Health video roundup covers the latest developments in regulatory actions, clinical trials, partnerships, and product launches. Key updates include significant approvals, clinical data releases, and regulatory decisions that could significantly impact patient care and treatment options.

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Transcript

Welcome to the latest edition of Women’s Health Updates, covering breakthroughs in the past two weeks. Brought to you by LucidQuest.

AstraZeneca’s Datroway, also known as datopotamab deruxtecan, has been granted FDA Priority Review as a first-line treatment for metastatic triple-negative breast cancer (TNBC). The TROPION-Breast02 trial demonstrated a significant improvement in overall survival for patients compared to traditional chemotherapy. This is a potential breakthrough for the 70% of TNBC patients who are not candidates for immunotherapy, providing them with a new treatment option.

However, AstraZeneca’s Saphnelo, an anifrolumab subcutaneous formulation, has received a complete response letter (CRL) from the FDA. The agency has requested additional information, and the company plans to resubmit its application. Meanwhile, the intravenous formulation remains available globally, but this delay means more data is needed before a decision can be made on the SC formulation.

In other news, Biogen’s Litifilimab has received FDA Breakthrough Therapy Designation for the treatment of cutaneous lupus erythematosus (CLE). This is a significant step forward, as Litifilimab is a first-in-class treatment targeting BDCA2 and shows promise in Phase 2 trials. Currently, there are no targeted therapies for CLE, so this designation could pave the way for a much-needed treatment option.

A recent study in the UK has found a possible link between menopause and Alzheimer’s-like brain changes, specifically the loss of grey matter in regions responsible for memory and emotion. The research suggests that hormonal changes during menopause may contribute to the increased incidence of Alzheimer’s disease in women. These findings underscore the importance of monitoring brain health during menopause for early intervention.

BioNxt has released promising final preclinical results for its cladribine sublingual oral dissolvable film (ODF), which demonstrated a 40% higher systemic drug delivery compared to conventional tablets. This formulation could offer enhanced patient compliance for multiple sclerosis (MS) treatment by improving systemic availability and potentially reducing side effects, thus optimizing dosing for better tolerability.

AbbVie has launched the “Love in Mind™” campaign, focusing on the emotional impact of migraines on romantic relationships. The campaign highlights how migraines affect relationship dynamics, with many patients reporting difficulty in maintaining intimacy and canceling social engagements during an attack. This initiative aims to raise awareness of the broader emotional toll of migraines and promote patient-centered care strategies.

Lundbeck presented real-world data from the INFUSE study, showing that its migraine treatment, Vyepti® (eptinezumab), has led to significant reductions in migraine frequency in patients who had failed previous treatments. Over 44% of patients experienced at least a 50% reduction in migraine days. This data could help establish new treatment standards, particularly for patients with a high disease burden.

Teva has announced a strategic partnership with Novartis to relaunch Mayzent® (siponimod) in Canada for multiple sclerosis patients. The partnership combines Teva’s expertise in MS with Novartis’s resources to ensure continued access to this important treatment, which will enhance the care available to MS patients in Canada and potentially influence drug pricing and accessibility.

In Japan, NorLevo, an emergency contraceptive pill, has become available over the counter for the first time. The pill is now accessible at over 5,400 pharmacies across Japan without a prescription, increasing access to emergency contraception. However, concerns have been raised regarding privacy and the potential for increased pricing.

Meanwhile, in Afghanistan, the Taliban has banned the use of contraceptive pills and shut down many reproductive health clinics. This ban has severely restricted women’s access to critical family planning options and further reduced reproductive healthcare services, impacting women’s health and autonomy in the country.

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Why It Matters

Datroway’s FDA Priority Review could significantly impact TNBC treatment, offering new hope for patients unable to use immunotherapy [1].
Saphnelo’s delay emphasizes the ongoing regulatory hurdles for lupus treatments [2].
Litifilimab’s designation highlights the growing interest in targeted therapies for autoimmune diseases like CLE [3].
The link between menopause and Alzheimer’s underscores the need for proactive brain health management in women [4].
BioNxt’s new cladribine delivery method could revolutionize MS treatment, offering better patient adherence and fewer side effects [5].
AbbVie’s “Love in Mind™” campaign sheds light on the emotional burden of migraine, affecting romantic relationships [6].
Lundbeck’s real-world Vyepti® data offers hope for better outcomes in chronic migraine patients [7].
Teva’s partnership with Novartis strengthens MS treatment access in Canada [8].
Over-the-counter contraceptives in Japan improve access, but raise concerns about privacy and pricing [9].
The Taliban’s ban on contraceptive pills presents significant challenges for women’s reproductive health in Afghanistan [10].

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FAQ

What is Datroway’s FDA Priority Review status for TNBC?

Datroway is under Priority Review for treating metastatic triple-negative breast cancer, showing improved overall survival compared to chemotherapy in clinical trials [1].

Why was Saphnelo’s SC formulation delayed?

The FDA issued a complete response letter for Saphnelo’s SC formulation, asking for additional information before approval can proceed [2].

What does FDA Breakthrough Designation mean for Litifilimab?

The designation expedites the development of Litifilimab for cutaneous lupus erythematosus, potentially offering a new treatment for a previously underserved patient population [3].

What were the findings of the UK study linking menopause to Alzheimer’s?

The study found that menopause is linked to changes in brain regions related to memory, which could increase Alzheimer’s risk in women [4].

How does BioNxt’s cladribine ODF improve MS treatment?

BioNxt’s cladribine ODF delivers 40% more drug to the bloodstream than traditional tablets, potentially improving efficacy and reducing side effects [5].

How does Abbvie’s Love in Mind campaign address migraine’s emotional toll?

The campaign highlights how migraines affect relationships and encourages open dialogue about the emotional challenges patients face [6].

Entities / Keywords

Datroway, TNBC, triple-negative breast cancer, Saphnelo, anifrolumab, lupus, litifilimab, BDCA2, cutaneous lupus, menopause, Alzheimer’s, cladribine, BioNxt, MS, Vyepti, migraine, Teva, Mayzent, Japan, contraceptives, Taliban, NorLevo, emergency contraception.

References

https://www.astrazeneca.com/media-centre/press-releases/2026/datroway-granted-priority-review-in-the-us-as-1st-line-treatment-for-patients.html
https://www.astrazeneca.com/media-centre/press-releases/2026/update-on-saphnelo-subcutaneous-administration.html
https://investors.biogen.com/news-releases/news-release-details/biogens-litifilimab-receives-fda-breakthrough-therapy
https://www.bbc.com/news/articles/c9qpp1g5ylvo
https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/bionxt-reports-final-preclinical-results-demonstrating-approximately-1129562
https://news.abbvie.com/2026-01-29-AbbVie-Launches-Love-in-Mind-TM-to-Spotlight-the-Emotional-Impact-of-Migraine-on-Romantic-Relationships
https://news.cision.com/h–lundbeck-a-s/r/lundbeck-presents-new-real-world-data-highlighting-meaningful-improvements-in-patients-severely-impa,c4298837
https://www.biospace.com/press-releases/teva-canada-announces-strategic-partnership-with-novartis-canada-to-relaunch-mayzent-for-multiple-sclerosis-patients-in-canada
https://japantimes.co.jp/news/2026/02/02/japan/science-health/emergency-contraceptive-pills-over-the-counter/
https://newspress.co.in/taliban-government-bans-use-of-contraceptive-pills-many-clinics-closed/