Eli Lilly and Co.’s Ebglyss (lebrikizumab) will be the latest U.S. entrant in the increasingly competitive atopic dermatitis space, following FDA approval of the IL-13-targeting antibody for use in adults and children, ages 12 and older, with moderate to severe disease not well controlled with topical therapies. The nod, delayed almost a year by manufacturing issues that resulted in a complete response letter in October 2023, will pit Ebglyss against blockbuster biologic Dupixent (dupilumab, Regeneron Pharmaceuticals Inc.), as well as more recently approved Adbry (tralokinumab, Leo Pharma Inc.) However, the positive clinical data and dosing schedule is expected to help Ebglyss gain traction, with Cortellis estimates indicating worldwide sales could top $1 billion as early as 2026.

Ascendis rises on achondroplasia phase III as Biomarin clipped

Shares of Copenhagen, Denmark-based Ascendis Pharma A/S (NASDAQ:ASND) were trading at $143.13, up $23.91, or 20%, on favorable top-line data from the pivotal double-blind placebo-controlled Approach trial with Transcon CNP (navepegritide), which included 84 children with achondroplasia (ages 2-11 years) randomized 2-to-1 (Transcon CNP or placebo). The compound is an investigational prodrug of C-type natriuretic peptide (CNP) given by subcutaneous (subcu) injection once weekly and designed to provide sustained release and continuous exposure to active CNP. Shares of competitor Biomarin Pharmaceutical Inc. (NASDAQ:BMRN) were selling for $72.47, down $12.43, or 14%. Biomarin, of San Rafael, Calif., markets Voxzogo (vosoritide), the CNP first approved by the U.S. FDA for the condition, a form of dwarfism, in November 2021. Granted an accelerated go-ahead, Voxzogo is given by way of a subcu shot once daily.

Genentech’s new multiple sclerosis treatment reduces admin time

Genentech’s newly approved multiple sclerosis (MS) injection takes 10 minutes to administer, dramatically reducing the time from its intravenous predecessor that took four to six hours. The U.S. FDA approved the humanized monoclonal antibody Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) for relapsing MS and primary progressive MS. The FDA approved Ocrevus, its predecessor, in 2017. Still, the new Ocrevus Zunovo will compete with Novartis AG’s anti-CD20 monoclonal antibody, Kesimpta (ofatumumab), which is self-administered at home with an autoinjector pen. FDA approved in 2020, its label includes clinically isolated syndrome and relapsing-remitting as well as active secondary progressive disease. Genentech is a unit of Roche Holding AG.

The massive, untapped opportunity in women’s health

Biocom California’s most recent edition of its Let's Talk About series covered the future of women’s health. The panel of executives from companies and investors in women’s health were frustrated about the state of funding for women’s health, but they were also hopeful that we could be at an inflection point where more investments will be made in the untapped market.

ESMO 2024: For T-cell target antigens, lots to see, but what to show?

Metastatic solid tumors may be curable now. Among the most profound results presented over the weekend at the European Society for Medical Oncology (ESMO) 2024 Congress were the 10-year data from the Checkmate-067 and Keynote-006 trials, the phase III trials that tested Opdivo (nivolumab, Bristol Myers Squibb Co.) and Keytruda (pembrolizumab, Merck & Co. Inc.) as first-line agents in advanced or metastatic melanoma. For patients treated with either Keytruda or Opdivo as monotherapy, 10-year overall survival (OS) topped 40%.

US FDA: Context matters in cancer trials

Putting in writing what it’s been saying at recent advisory committee meetings, the U.S. FDA is issuing a draft guidance on multiregional clinical trials for cancer drugs that underscores the need for applicability to the U.S. population and medical practices. Noting the continuing decrease in the proportion of U.S. participants in multiregional oncology trials, the agency said the demographic and clinical characteristics of trial participants may differ significantly from the U.S. population, sometimes to the extent that the results are inappropriate to support an FDA regulatory decision. “The FDA encourages sponsors to pursue multiregional clinical trials, but stresses that such trials should be conducted within the appropriate context,” said Richard Pazdur, director of the FDA’s Oncology Center of Excellence and acting director of its Office of Oncologic Diseases.

ESMO 2024: Immvira’s MVR-T3011 shows early efficacy in bladder cancer

Immvira Group Co.’s oncolytic herpes simplex virus product, MVR-T3011, showed early efficacy via intravesical administration in patients with high-risk BCG-failure non-muscle invasive bladder cancer. Conducted in China, the phase I, open-label, dose-escalation study assessed the safety and efficacy of MVR-T3011 administered intravesically, or directly to the bladder. Results were presented via a poster presentation at the European Society for Medical Oncology (ESMO) 2024 Congress.

Senators send stern message to US FDA on animal testing

While it’s called the FDA Modernization Act 3.0, the bipartisan bill introduced in the U.S. Senate last week is basically a message to the FDA: the FDA Modernization Act 2.0 wasn’t a congressional suggestion; it’s a requirement. That act, passed two years ago, called on the agency to “remove overbearing and often unnecessary animal testing requirements on new drugs,” said Sen. Eric Schmitt (R-Mo.), one of the sponsors of the 3.0 bill. But the FDA has yet to update its regulations to conform with the 2022 law, leaving in place numerous regulations requiring animal testing. The new legislation would give the agency six months to fully implement the modernized testing requirements included in the 2.0 act.

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