Articles related to DEVICE/DRUG APPROVALS

The SSRI inhibitor was previously limited to adults. As physicians, we are continually seeking effective treatment options for our pediatric patients. The recent FDA approval of Lexapro for pediatric GAD treatment marks a significant advancement in this field.

Unveiling a new path in osteoarthritis pain management, the FDA’s Breakthrough Therapy designation for resiniferatoxin marks a promising development. The FDA has granted Breakthrough Therapy designation to resiniferatoxin for treating osteoarthritis knee pain. Extracted from a cactus-like plant, resiniferatoxin, a potent TRPV1 agonist, boasts similarities to capsaicin. Notably, its potency sets it apart. Resiniferatoxin is administered through intra-articular injection, promoting pain relief by temporarily disabling TRPV1-expressing nociceptors. This unique mechanism targets one of the most profound symptoms of osteoarthritis: pain. Its potential benefits are eagerly awaited by millions of patients struggling with this relentless disease. Stepping up to the challenge, Grünenthal, the company behind resiniferatoxin, is launching a global Phase 3 program. They aim to enroll more than 1,800 patients with knee osteoarthritis who haven’t found sufficient relief from existing non-surgical treatments. With a focus on improved pain and physical function scores according to the WOMAC osteoarthritis index, the program’s efficacy endpoints are set for up to 52 weeks. Turning the tide in osteoarthritis treatment, the Breakthrough Therapy Designation offers an expedited path for this non-opioid therapy option. As Grünenthal’s Chief Scientific Officer, Jan Adams, optimistically noted, it is hoped that this designation will speed up resiniferatoxin’s availability to patients.

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 […]