ALD-1910

Lundbeck Expands PROCEED Trial to Include Intravenous Administration of Novel Anti-PACAP Antibody for Migraine Prevention

2 months ago

• Following a planned interim analysis of the Phase IIb PROCEED trial, Lundbeck will expand testing of Lu AG09222, a first-in-class anti-PACAP monoclonal antibody, to include intravenous administration for migraine prevention. • The trial targets patients with migraine who have failed 1-4 previous preventive treatments, addressing a significant unmet need affecting an estimated 2.5-3.0 million patients in G7 countries. • The PROCEED trial is expected to complete in the first half of 2026, with pivotal Phase III trials planned to begin in the second half of 2026, potentially offering a new treatment pathway distinct from CGRP-targeting therapies.

FDA Gears Up for Critical Decisions on Alzheimer's, Breast Cancer, and Neurological Therapies in Early 2025

5 months ago

• The FDA is set to decide on Biogen and Eisai's Leqembi for monthly intravenous maintenance in early Alzheimer's disease, potentially improving patient convenience. • AstraZeneca and Daiichi Sankyo await a decision on Dato-DXd for metastatic HR-positive, HER2-negative breast cancer, offering a new antibody-drug conjugate approach. • Vertex's suzetrigine, a non-opioid analgesic for moderate-to-severe acute pain, anticipates FDA verdict, representing a novel drug class for pain management. • SpringWorks' mirdametinib is under priority review for neurofibromatosis type 1-associated plexiform neurofibromas, addressing a significant unmet need.

Migraine Treatment Advances: CGRP Inhibitors, Digital Therapeutics, and Novel Compounds Highlight 2024

5 months ago

• The American Headache Society now recommends CGRP-targeting therapies as a first-line approach for migraine prevention, marking a significant shift in treatment strategy. • Nerivio, a remote electrical neuromodulation device, received FDA approval for expanded use in pediatric patients aged 8 and older for acute migraine treatment. • Clinical trials show promise for digital therapeutic CT-132 in reducing monthly migraine days, offering a novel non-pharmacological option for episodic migraine prevention.

FDA Accepts Satsuma and SNBL's NDA Resubmission for STS101 Migraine Treatment

7 months ago

• The FDA has accepted for review Satsuma Pharmaceuticals and SNBL's resubmitted NDA for STS101, a dihydroergotamine nasal powder, for acute migraine treatment. • The PDUFA date is set for April 30, 2025, offering hope for the nearly 40 million Americans suffering from migraine, especially women in their 20s to 40s. • STS101 is designed for quick self-administration, leveraging a proprietary nasal delivery device for rapid DHE absorption and sustained plasma concentrations. • The resubmission addresses FDA's previous concerns related to formulation, with no additional clinical trials requested, marking a significant step toward potential approval.

Lundbeck to Acquire Longboard Pharmaceuticals for $2.6 Billion, Bolstering Epilepsy Pipeline

7 months ago

• Lundbeck will acquire Longboard Pharmaceuticals for $2.6 billion, gaining bexicaserin, a promising drug for developmental and epileptic encephalopathies (DEEs). • Bexicaserin, a 5-HT2C receptor superagonist, has shown encouraging results in clinical trials for reducing seizure frequency in Dravet syndrome and other DEEs. • The acquisition aligns with Lundbeck's strategy to expand its neuro-rare disease portfolio, with bexicaserin potentially launching in 2028 and reaching peak sales of $1.5-2 billion. • The deal is expected to close in the fourth quarter of 2024, pending regulatory approvals and tender of Longboard's outstanding shares.

Lundbeck Initiates Phase I Trial of Lu AG09222 for Migraine Prevention

9 months ago

• Lundbeck has commenced a Phase I clinical trial to evaluate Lu AG09222, a second-generation migraine drug, as a potential combination therapy for migraine prevention. • The trial aims to assess the safety, tolerability, and pharmacokinetic profile of Lu AG09222 when administered in combination with other migraine treatments. • Lu AG09222 represents Lundbeck's "most promising" candidate for migraine, reflecting the company's commitment to addressing this debilitating neurological condition.