New drug authorized for critically ill patients with COVID-19
The FDA granted emergency use authorization for Gohibic (vilobelimab) for critically ill adults with COVID-19 who are on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO). Gohibic is a monoclonal antibody that must be initiated within 48 hours of mechanical ventilation or ECMO initiation.
In clinical trials, Gohibic was shown to reduce all-cause mortality in those receiving it in comparison with those receiving placebo and standard care (32% versus 42%). Gohibic is administered via I.V. infusion for a maximum of six 800-mg doses.
Common adverse reactions in clinical trials included pneumonia, sepsis, delirium, pulmonary embolism, hypertension, and pneumothorax. There is a risk for serious allergic reactions to the drug, and it could lower the patient's ability to fight infections.
OTC naloxone nasal spray approved
Narcan (naloxone hydrochloride), 4-mg nasal spray has been approved by the FDA for over-the-counter (OTC) use, making it the first naloxone product approved for use without a prescription. Use of Narcan is the standard treatment for opioid overdose, as it blocks the effects of this drug class and rapidly reverses the condition. The OTC approval allows this life-saving medication to be sold directly to consumers in places such as convenience stores, grocery stores, pharmacies, and gas stations, as well as online.
According to the FDA, the timeline for availability and price of the OTC product is determined by the manufacturer. OTC availability may take months to achieve; other formulations and dosages of naloxone will remain available via prescription only.
Narcan is a product of Emergent BioSolutions.
FDA approves long-acting antifungal for Candida treatment
The FDA approved the once-weekly, long-acting antifungal Rezzayo (rezafungin) for injection in adults with limited or no alternative options to treat candidemia and invasive candidiasis. Rezzayo is the first new treatment option for candidemia and invasive candidiasis in more than 10 years.
Rezzayo is administered as a 400-mg loading dose followed by 200-mg doses weekly. Rezzayo may cause infusion-related reactions, such as flushing, urticaria, nausea, or chest tightness. If these reactions occur, the infusion should be slowed or paused. The drug may also cause photosensitivity; patients should be advised to use protection from sun exposure and other sources of UV radiation.
The drug is a product of Cidara Therapeutics and Melinta Therapeutics.
Clinical trial shows importance of matching patients to specific BP medications
The Precision Hypertension Care (PHYSIC) study has demonstrated considerable differences in individual responses to hypertension medications, according to Swedish researchers, who said that the study showed evidence that there is potential for greater BP reductions with a personalized therapy choice than with a fixed choice.
The randomized trial involved adult patients with hypertension taking four antihypertension drugs (lisinopril, candesartan, hydrochlorothiazide, and amlodipine) in random order and evaluated the effect on ambulatory daytime systolic BP. Treatment responses to the drugs differed significantly among individuals, specifically for lisinopril versus hydrochlorothiazide; lisinopril versus amlodipine; candesartan versus hydrochlorothiazide; and candesartan versus amlodipine.
There were 1,468 completed treatment periods in 270 of 280 randomized participants. On average, personalized treatment had the potential to lower systolic BP by an additional 4.4 mm Hg in comparison with standard treatment. The researchers indicated that the additional BP reduction achieved through personalization constituted, on average, twice that achieved by doubling the first drug's dose and more than half the reduction achieved by adding a second drug, both of which are standard second-line treatments.