FDA OKs Olaparib-Abiraterone for Metastatic Prostate Cancer
The FDA has approved the PARP inhibitor olaparib (Lynparza) in combination with abiraterone (Zytiga) for BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC), the agency announced Wednesday. Adult patients should be selected for the combination therapy — which is given with prednisone (or prednisolone) — based on an FDA-approved companion diagnostic test to detect deleterious or suspected […]
Second RSV Vaccine Lands Approval for Older Adults
The FDA has approved a second respiratory syncytial virus (RSV) vaccine for preventing lower respiratory infections in adults 60 and over, Pfizer announced on Wednesday. Approval of the unadjuvanted, bivalent RSV prefusion F protein vaccine (Abrysvo) follows an endorsement in March from FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC). Advisors voted 7-4 in […]
Sotagliflozin Gets FDA’s Blessing for Heart Failure
After a rocky development and regulatory road, the FDA has approved sotagliflozin (Inpefa) for treating heart failure in patients with or without diabetes, manufacturer Lexicon Pharmaceuticals announced on Friday. The dual SGLT1 and SGLT2 inhibitor is indicated for reducing the risk of cardiovascular death and urgent visits or hospitalization for heart failure in adults with […]
FDA OKs Hormone-Free Pill for Hot Flashes
The FDA approved the first-in-class drug fezolinetant (Veozah) for the treatment of moderate to severe hot flashes caused by menopause, the agency announced Friday. The oral neurokinin 3 (NK3) receptor antagonist is a non-hormonal treatment that works to block the activities of the NK3 receptor, which plays a role in the brain’s regulation of body […]
Do Orphan Drugs Really Need Development Incentives?
Drugs approved for an “orphan” indication ended up making just as much money as their non-orphan counterparts, even though they were helped by incentives during development, researchers found. There was no significant difference in median 5-year net sales between orphan and non-orphan drugs ($719 million vs $812 million, P=0.09), reported Benjamin Rome, MD, MPH, of […]
Opinion | Marijuana Is Not the Solution for PTSD
A growing number of states have identified post-traumatic stress disorder (PTSD) as an approved condition for medical marijuana. According to Colorado’s Medical Marijuana Registry, there are 70,533 patients as of February 2023 with an active medical marijuana registration in the state, and 10,734 of them indicate PTSD as the reason they are using medical marijuana. […]
First Treatment Approved for Rare Genetic Neurologic Disorder
The FDA approved trofinetide (Daybue), the first drug to treat adult and pediatric patients age 2 and older with Rett syndrome, drugmaker Acadia Pharmaceuticals announced Friday. “Now, for the first time after decades of clinical research, healthcare providers finally have a treatment option to address a range of core behavioral, communication, and physical symptoms for […]
Fast-Acting Nasal Spray for Migraine Snags FDA Approval
The FDA approved intranasal zavegepant (Zavzpret) for acute migraine, making it the first calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray with this indication, drugmaker Pfizer announced on Friday. Zavegepant is indicated for the treatment of migraine with or without aura, and is not indicated for preventing migraine. The pathophysiology of migraines is related to […]
FDA Approves First Treatment for Geographic Atrophy Secondary to AMD
The FDA approved pegcetacoplan injection (Syfovre) as the first treatment for geographic atrophy (GA) secondary to age-related macular degeneration (AMD), according to a statement from Apellis Pharmaceuticals. Primary support for the approval came from the randomized, sham-controlled DERBY and OAKS trials, which showed a 22% overall reduction in growth of GA with pegcetacoplan over 24 […]
Alzheimer’s Drug Lecanemab Wins FDA Approval
Lecanemab (Leqembi) was approved under the accelerated approval pathway to treat Alzheimer’s disease, the FDA announced on Friday. The anti-amyloid should be started only in patients with mild cognitive impairment or who are at the mild dementia stage of Alzheimer’s disease, the population studied in clinical trials, the agency noted, and the drug label indicates […]