Significant Pain Relief Observed With Intranasal Zavegepant in Migraine Trial
Zavegepant is an investigational calcitonin gene-related peptide (CGRP) receptor antagonist.
Zavegepant is an investigational calcitonin gene-related peptide (CGRP) receptor antagonist.
The update follows the FDA’s Drug Safety Communication, which was based on a completed review of a large randomized safety clinical trial evaluating tofacitinib in patients with rheumatoid arthritis.
The STEP 5 trial compared Wegovy to placebo in 304 adults who were overweight (BMI ≥27kg/m2) or obese (BMI ≥30kg/m2) over 2 years.
The application is supported by data from the pivotal phase 3 POETYK PSO-1 and POETYK PSO-2, which included patients with moderate to severe plaque psoriasis.
The phase 3 BE OPTIMAL study included 852 adults with active psoriatic arthritis who were biologic disease-modifying antirheumatic drug naïve.
The investigational intranasal formulation of nalmefene demonstrated a more rapid onset and longer duration of action compared with naloxone.
Paxlovid is an investigational SARS-CoV-2 protease inhibitor consisting of PF-07321332 and low-dose ritonavir.
Maxigesic is a combination of acetaminophen 1000mg and ibuprofen 300mg for IV infusion.
The FDA’s Fast Track process allows for expedited review of drugs that are expected to fill an unmet need.
The DISCOVER-2 trial included 739 biologic-naïve adults with active psoriatic arthritis who were treated and followed for approximately 2 years.