Editors' (re)View: Hot flash treatment space heats up; Alzheimer's resilience

May 17, 2024
Pharma Manufacturing editors Karen Langhauser and Andrea Corona comment on the notable happenings in the pharma industry from the week of May 13

Alzheimer's resilience

Earlier this week, Takeda signed a worldwide licensing agreement that could reach $2.1 billion with Swiss biotech AC Immune to develop and commercialize ACI-24.060, an immunotherapy targeting amyloid beta plaques for treating Alzheimer's disease.

Despite significant investments and numerous trials, the success rate for Alzheimer's drug development remains extremely low. AC Immune has encountered notable setbacks in its search for an effective Alzheimer’s treatment. In 2019, Roche and AC Immune discontinued a phase 3 trial of crenezumab, an early Alzheimer’s treatment, after it was found ineffective.

Despite this setback to the hypothesis that blocking amyloid plaques could slow cognitive decline, Roche continued to study crenezumab in healthy individuals with a genetic predisposition to Alzheimer’s. Earlier this year, AC Immune regained all global rights to crenezumab and said they would continue advancing phase 2 development of the antibody for Alzheimer’s disease. 

In 2020, Roche and AC Immune faced another challenge when their experimental Alzheimer's treatment, semorinemab, failed to improve cognitive function in a phase 2 trial with early-stage patients. Unlike many treatments targeting amyloid beta peptides, semorinemab focused on tau proteins, but did not prove more effective.

Earlier this year, Biogen’s controversial Aduhelm was discontinued. For Aduhelm, the writing was on the wall. The drug faced a tumultuous approval process, unfavorable national coverage policies in the U.S., and finally, a failed observational trial. 

With a 99% rejection rate for drugs targeting the disease, the outlook remains mostly grim for patients seeking effective treatments. However, a glimmer of hope may be on the horizon.

Last year, the FDA changed the approval status of Eisai's Alzheimer's treatment, Leqembi, from accelerated to traditional approval. Initially approved in January through the Accelerated Approval pathway amid controversy, Leqembi was linked to two clinical trial deaths when used with blood thinners in November 2022. Despite these concerns, it received accelerated approval based on its ability to reduce amyloid plaques.

The story here is one of resilience. Despite notable setbacks and a high failure rate, pharma companies continue to push forward, driven by an urgent need for an effective Alzheimer’s treatment.  — Andrea Corona 

Menopause symptoms are treatable, but payer support is lukewarm

This week, Bayer shared additional results from phase 3 trials for a new menopause symptoms drug, elinzanetant. The drug hit both primary and secondary endpoints in the trials, improving hot flashes and sleep disturbances associated with menopause.

If approved, elinzanetant will offer a second treatment option for those suffering from menopause symptoms.  Astellas won approval for its drug, branded Veozah, a year ago. Both drugs are taken orally once daily. Elinzanetant targets two receptors in the brain: NK-3, which regulates body temperature and NK-1, which affects mood and sleep. Veozah targets the NK3 receptor.

Importantly, both drugs offer non-hormonal treatment. Hormone replacement therapy — estrogen or estrogen coupled with progestin — is often recommended during menopause, but such treatments carry breast cancer risks and can't be taken by breast cancer survivors.

With over 50 million women reaching menopause each year in the U.S., it’s about time that treatment options are available. But there’s a familiar catch — insurance companies are reluctant to pay for the drugs. Without insurance coverage, a 30-day supply of the Astellas drug can cost $550.

But the pressure for payers to actually pay is heating up, as menopause appears to be finally getting its moment. Celebrities have joined the fight, with notable names like Gwyneth Paltrow, Oprah Winfrey and Gillian Anderson speaking up about the challenges of menopause. A new $275 million bill (with the celebrity backing of Halle Berry) aimed at improving menopause care and treatment has been introduced to Congress. The bill seeks to bolster menopause-related research, improve methods of detection and treatment, and address misinformation.

Women’s health has been tragically underfunded and understudied, so it’s encouraging to see the space finally getting the attention it deserves — and hopefully, this leads to better access for the millions affected. —Karen Langhauser







About the Author

Karen P. Langhauser | Chief Content Director, Pharma Manufacturing

Karen currently serves as Pharma Manufacturing's chief content director.

Now having dedicated her entire career to b2b journalism, Karen got her start writing for Food Manufacturing magazine. She made the decision to trade food for drugs in 2013, when she joined Putman Media as the digital content manager for Pharma Manufacturing, later taking the helm on the brand in 2016.

As an award-winning journalist with 20+ years experience writing in the manufacturing space, Karen passionately believes that b2b content does not have to suck. As the content director, her ongoing mission has been to keep Pharma Manufacturing's editorial look, tone and content fresh and accessible.

Karen graduated with honors from Bucknell University, where she majored in English and played Division 1 softball for the Bison. Happily living in NJ's famed Asbury Park, Karen is a retired Garden State Rollergirl, known to the roller derby community as the 'Predator-in-Chief.'