University of Vermont

German drugmaker Boehringer Ingelheim didn’t share any data behind the top-line result, instead promising that the efficacy and safety findings would be unveiled in the second quarter.\n Boehringer Ingelheim has cemented the potential of its idiopathic pulmonary fibrosis (IPF) drug with a second phase 3 win in a related lung disease leading the drugmaker to expand the indications it will seek FDA approval for.The FIBRONEER-ILD trial saw 1,178 patients with progressive pulmonary fibrosis (PPF) receive either a 9 mg or 18 mg dose of the PDE4B inhibitor nerandomilast or placebo twice a day for 52 weeks. The study hit its primary endpoint of demonstrating an absolute change from baseline in forced vital capacity—a measure of the volume of air that a patient can breathe out—Boehringer said in a Feb. 10 release.The German drugmaker didn’t share any data behind the top-line result, instead promising that the efficacy and safety findings would be unveiled in the second quarter.“Initial data readouts of the FIBRONEER trials support a generally consistent safety and tolerability profile when compared to the phase 2 IPF study, with overall adverse events comparable to those seen in the placebo group,” the company said.Armed with the latest results, Boehringer said it will request that FDA and global regulators approve nerandomilast as a treatment for PPF, a type of interstitial lung disease. The company has already said it will seek approval for nerandomilast in IPF after proclaiming a win in a phase 3 trial for that lung disease in September 2024. Again, the company opted to hold back any concrete data from that trial for later in this year.When it comes to managing IPF, physicians already have Boehringer’s Ofev and Roche’s Esbriet. However, those drugs only slow the progression of fibrosis, while attempts to produce molecules that further slow, or ideally stop, progression have failed to prove their worth.By targeting phosphodiesterase 4B (PDE4B), nerandomilast is meant to have a mechanistic advantage over the incumbent products. Targeting PDE4 drives anti-inflammatory and antifibrotic effects, but attempts to develop oral inhibitors of the enzyme in respiratory diseases have been hindered by class-related systemic adverse events such as diarrhea and headaches.“The positive FIBRONEER-ILD topline result shows the potential of nerandomilast in progressive pulmonary fibrosis,” Shashank Deshpande, Head of Human Pharma at Boehringer, said in the release. “The hope is that the safety and tolerability profile we are initially seeing could potentially help to reduce treatment challenges.”

MONDAY, Feb. 3, 2025 -- A common drug used to prevent migraines might have an additional benefit -- protecting women against stroke . Women taking the beta blocker propranolol to ward off migraines have a lower risk of strokes caused by blood clots , according to new research to be presented Thursday at a meeting of the American Stroke Association. The risk of stroke was as much as 52% lower in female migraine sufferers taking propranolol, which is available as a generic drug, researchers said. The drug did not have the same protective effect for men, however. “Migraine is an often-ignored risk factor for cardiovascular issues. Until recently, preventive treatments for people who have migraines were not available,” said lead researcher Mulubrhan Mogos , an assistant professor at Vanderbilt University School of Nursing in Nashville, Tenn. About 20% of people suffer from migraines, researchers said in background notes. Migraine headaches occur three times more often in women than men, and they are associated with an increased risk of stroke. Beta blockers are commonly prescribed to help ward off migraine, and also are used to treat high blood pressure. For their study, researchers reviewed more than 3 million electronic health records from two large databases. They identified people with migraine who had a stroke, and then checked who was taking propranolol for migraine. “We initially looked at overall stroke and then ischemic (clot-caused) stroke specifically,” Mogos said. “We refined our analysis further by controlling for possible confounders and found the association is significant and stronger for ischemic stroke.” In one database, the risk of stroke was 52% lower in female migraine sufferers taking propranolol. The risk was 39% lower in the other database. The protective effect was stronger for women who suffer migraine without aura. Migraine aura can cause visual hallucinations like flashing lights, blind spots, zigzag patterns or colored spots. “Migraine without aura may often be overlooked as a risk factor for stroke, especially in women, in whom previous literature has demonstrated that migraine is a stronger, more important risk factor compared with men,” Dr. Tracy Madsen , chair of the American Heart Association Clinical Cardiology/Stroke Women’s Health Science Committee, said in a news release. “The study’s findings are not surprising since we have strong evidence that medications similar to propranolol used to treat blood pressure reduce stroke risk substantially,” added Madsen, who is an associate professor of emergency medicine at the University of Vermont and was not involved in the study. “The findings are potentially quite helpful, though, for women living with frequent migraine, as they suggest we have a good medication option that helps to prevent both migraines and strokes,” she added. The fact that a generic drug can prevent migraine in some women and also protects against stroke could be a boon for poorer patients, Mogos said. “Our findings indicate that women and health care professionals should discuss the advantages of preventive migraine interventions,” Mogos said. “For under-resourced individuals who bear a greater burden from this condition and may lack access to new treatments, we must ensure these treatments are available to them. This approach can help reduce health disparities.” The meeting runs Wednesday through Friday in Los Angeles. Findings presented at medical meetings should be considered preliminary until published in a peer-reviewed journal. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

MONDAY, Feb. 3, 2025 -- A common drug used to prevent migraines might have an additional benefit -- protecting women against stroke . Women taking the beta blocker propranolol to ward off migraines have a lower risk of strokes caused by blood clots , according to new research to be presented Thursday at a meeting of the American Stroke Association. The risk of stroke was as much as 52% lower in female migraine sufferers taking propranolol, which is available as a generic drug, researchers said. The drug did not have the same protective effect for men, however. “Migraine is an often-ignored risk factor for cardiovascular issues. Until recently, preventive treatments for people who have migraines were not available,” said lead researcher Mulubrhan Mogos , an assistant professor at Vanderbilt University School of Nursing in Nashville, Tenn. About 20% of people suffer from migraines, researchers said in background notes. Migraine headaches occur three times more often in women than men, and they are associated with an increased risk of stroke. Beta blockers are commonly prescribed to help ward off migraine, and also are used to treat high blood pressure. For their study, researchers reviewed more than 3 million electronic health records from two large databases. They identified people with migraine who had a stroke, and then checked who was taking propranolol for migraine. “We initially looked at overall stroke and then ischemic (clot-caused) stroke specifically,” Mogos said. “We refined our analysis further by controlling for possible confounders and found the association is significant and stronger for ischemic stroke.” In one database, the risk of stroke was 52% lower in female migraine sufferers taking propranolol. The risk was 39% lower in the other database. The protective effect was stronger for women who suffer migraine without aura. Migraine aura can cause visual hallucinations like flashing lights, blind spots, zigzag patterns or colored spots. “Migraine without aura may often be overlooked as a risk factor for stroke, especially in women, in whom previous literature has demonstrated that migraine is a stronger, more important risk factor compared with men,” Dr. Tracy Madsen , chair of the American Heart Association Clinical Cardiology/Stroke Women’s Health Science Committee, said in a news release. “The study’s findings are not surprising since we have strong evidence that medications similar to propranolol used to treat blood pressure reduce stroke risk substantially,” added Madsen, who is an associate professor of emergency medicine at the University of Vermont and was not involved in the study. “The findings are potentially quite helpful, though, for women living with frequent migraine, as they suggest we have a good medication option that helps to prevent both migraines and strokes,” she added. The fact that a generic drug can prevent migraine in some women and also protects against stroke could be a boon for poorer patients, Mogos said. “Our findings indicate that women and health care professionals should discuss the advantages of preventive migraine interventions,” Mogos said. “For under-resourced individuals who bear a greater burden from this condition and may lack access to new treatments, we must ensure these treatments are available to them. This approach can help reduce health disparities.” The meeting runs Wednesday through Friday in Los Angeles. Findings presented at medical meetings should be considered preliminary until published in a peer-reviewed journal. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.