Articles related to FDA

Dive into the implications of the FDA’s approval of nirmatrelvir+ritonavir, the first oral antiviral pill for COVID-19. The FDA’s recent approval of nirmatrelvir+ritonavir (Paxlovid, Pfizer) marks a significant advancement in COVID-19 treatment. This oral antiviral, the first of its kind, targets mild to moderate cases in high-risk adults. It’s the fourth drug, but the first pill, to gain FDA approval for treating adult COVID-19 patients. Nirmatrelvir+ritonavir will remain available under emergency use authorization, ensuring continued access for adults and for eligible 12-18 year olds. However, it’s not approved for pre- or post-exposure COVID-19 prevention. Patrizia Cavazzoni, MD, the director for the FDA’s Center for Drug Evaluation and Research, applauded the drug’s approval. She stressed the agency’s commitment to advancing new prevention and treatment options. The efficacy of nirmatrelvir+ritonavir comes primarily from the EPIC-HR clinical trial. This trial studied nonhospitalized symptomatic adults diagnosed with SARS-CoV-2 infection. In the study, nirmatrelvir+ritonavir reduced COVID-19–related hospitalizations or deaths by 86% compared to placebo when used within five days of symptom onset. Almost equal numbers of patients received nirmatrelvir+ritonavir and a placebo. Only 0.9% of the combo pill group were hospitalized or died within 28 days of follow-up, compared to 6.5% in the placebo group. […]

Dive into how the FDA-approved Farxiga is changing the heart failure treatment landscape. Colleagues, let’s dive into a remarkable milestone. Farxiga, known as dapagliflozin, now has FDA approval. This is groundbreaking for heart failure treatment. It applies to all patients, regardless of their left ventricular ejection fraction (LVEF) status. The approval didn’t happen overnight. Let’s talk about the DELIVER trial, a vital part of the process. It involved over 6,000 patients, all over 40. Each had heart failure, LVEF above 40%, and may or may not have had type 2 diabetes. They took either dapagliflozin or a placebo daily, plus their usual therapy. The trial had a clear goal: time to the first composite event. This included CV death, heart failure hospitalization, or an urgent heart failure visit. The goal applied to everyone, including patients with LVEF less than 60%. Fast forward about 2.3 years, the results were significant. Dapagliflozin cut the composite outcome by 18% versus the placebo. Both worsening heart failure and CV death rates dropped in the dapagliflozin group. The best part? These findings were consistent, even in patients with lower LVEF or diabetes. Expanding the picture, let’s consider two trials together: DELIVER and DAPA-HF. Over 22 […]

The FDA’s controversial approval of Recarbrio in 2019 marked a deviation from the expected standards of drug effectiveness. Before 1962, US drug approvals didn’t require pre-market proof of effectiveness. Following Senate hearings and the Thalidomide disaster, however, the law changed. Nowadays, FDA approval for new drugs requires substantial evidence of effectiveness from well-controlled investigations. Strikingly, a National Academy of Sciences review found over 30% of pre-1962 drugs to be ineffective, highlighting the importance of these regulations. FDA’s regulations provide a detailed explanation of what constitutes substantial evidence. Though not perfect, these regulations reassure prescribers, patients, and payers of the scientific basis of drug efficacy claims. It’s important to note that an FDA review found 59% of rejected NDAs had deficiencies in efficacy evidence. Nevertheless, the FDA’s controversial approval of Recarbrio in 2019 raised eyebrows. This drug, a combination of imipenem, cilastatin, and relebactam, was approved despite lacking substantial evidence of effectiveness and proper clinical investigations. Disturbingly, FDA officials cited animal and laboratory studies as substantial evidence, a move contrary to legal and regulatory norms. Moreover, the Recarbrio approval showcased other troubling departures from regulatory principles. The FDA failed to require proof of each active component’s contribution to the claimed effect. […]

FDA’s New Approval of Atogepant for Chronic Migraine Prevention is a Breakthrough in Migraine Management A promising breakthrough in migraine management, the FDA’s new approval of atogepant tablets, brings renewed hope for chronic migraine sufferers. According to AbbVie, this endorsement allows the use of atogepant (Qulipta) in the prevention of chronic migraines in adults. Atogepant stands out as the first oral calcitonin gene-related peptide (CGRP) receptor antagonist to receive dual approval for episodic and chronic migraines. It works by blocking CGRP, a molecule involved in transmitting pain signals. Chronic migraines, to clarify, involve enduring headaches for at least 15 days a month, with eight of those days associated with migraines. Before this, in September 2021, the FDA approved atogepant for treating episodic migraines. Patients can take the drug in 10 mg, 30 mg, and 60 mg dosages. The FDA recommends the 60 mg dose for chronic migraine patients. Peter McAllister, MD, from the New England Center for Neurology and Headache, noted that the FDA’s endorsement offers a new, convenient daily treatment for chronic migraine patients. The demonstrated efficacy and functional improvement of atogepant make it an appealing option for neurologists and headache specialists when devising treatment plans for patients. The […]

Demonstrating compelling efficacy in the EV-103 trial, the combination of enfortumab vedotin-ejfv and pembrolizumab emerges as a promising treatment for patients with locally advanced or metastatic urothelial carcinoma ineligible for cisplatin-based chemotherapy. The recent approval of enfortumab vedotin-ejfv in combination with pembrolizumab for patients with locally advanced or metastatic urothelial carcinoma (la/mUC) who are ineligible for cisplatin-based chemotherapy was substantiated by compelling results from the multi-cohort Phase 1b/2 EV-103 trial. In the dose escalation cohort and cohort A of the trial, patients received this innovative combination therapy. In cohort K, patients were randomized to receive either the combination or enfortumab vedotin-ejfv monotherapy. The main efficacy outcome measures were the objective response rate (ORR) and duration of response (DOR), with the ORR reaching 68% (95% CI, 58.7-76.0) among the 121 patients who received the combination therapy. Moreover, the median DOR was reported as 22.1 months for the dose escalation and cohort A. Nevertheless, patients did report a range of adverse reactions, most commonly increased glucose, increased aspartate aminotransferase, rash, and decreased hemoglobin, among others. The approval of this therapy is dependent on the validation and depiction of clinical benefits from the ongoing Phase 3 EV-302 confirmatory trial. Given the promising ORR […]

The FDA has granted clearance for Casana’s Heart Seat™ toilet seat to be used in homes for monitoring heart rate and oxygen saturation (SpO2) in adults aged 22 and above, weighing between 90 and 350 pounds. The toilet seat is equipped with sensors that can measure these vital signs and transmit the data to the Casana Cloud automatically. Healthcare providers can then access the data generated by three sensors: a ballistocardiogram, which measures heart mechanical activity; an electrocardiogram, which measures heart electrical activity; and a photoplethysmogram, which detects blood volume changes. A study assessing the accuracy of the seat demonstrated consistent measurements of blood pressure, stroke volume, and blood oxygenation compared to a hospital-grade vital signs monitor. Casana intends to conduct further testing and plans to submit an application to the FDA this year to include additional clinical measurements, such as blood pressure monitoring. The Heart Seat is expected to be available by the end of 2023.