Seladelpar (Livdelzi – Gilead), a peroxisome proliferator-activated receptor (PPAR)-delta agonist, has received accelerated approval from the FDA for use in combination with ursodeoxycholic acid (ursodiol, UDCA; Urso Forte, and generics) for treatment of primary biliary cholangitis (PBC) in adults who had an inadequate response to UDCA and as monotherapy in those unable to tolerate UDCA. Accelerated approval was based on a reduction in alkaline phosphatase (ALP) levels. Seladelpar is the second PPAR agonist to be approved in the US for this indication; elafibranor (Iqirvo)...

Nicardipine (Cardene - Syntex), a dihydropyridine calcium-entry blocker structurally related to nifedipine (Procardia; Adalat), was recently approved by the US Food and Drug Administration for oral treatment of angina and hypertension. Advertisements for the drug claim that nicardipine is more vasoselective; than other calcium-channel blockers and does not depress myocardial contractility.

Zaleplon, a pyrazolopyrimidine hypnotic, was recently approved by the FDA for short-term treatment of insomia. Zaleplon, like zolpidem, is a non-benzodiazepine that binds to benzodiazepine receptors.

Budesonide (Entocort EC — AstraZeneca), a locally active glucocorticosteriod widely used for inhalation treatment of allergic rhinitis and asthma (Medical Letter 2000; 42:19), has been approved for oral treatment of mild to moderate active Crohn's disease involving the ileum and/or ascending colon. Both oral budesonide and budesonide enemas have been available for years in Europe and Canada for treatment of inflammatory bowel disease.

The FDA has approved pegvisomant (Somavert Pfizer), a growth hormone receptor antagonist, for parenteral treatment of acromegaly in patients who are not candidates for or have had an inadequate response to surgery or other treatment. This review describes the disease of acromegaly and its standard treatment options. Also included are sections on the mechanism of action, pharmacokinetics, adverse effects, drug interactions, and the dosage and cost of pegvisomant. Results of clinical studies are discussed. The conclusion provides an overall assessment of the prospects for this new drug.

The FDA has approved a new formulation of carbidopa/levodopa (Rytary – Impax) in extended-release capsules for treatment of Parkinson’s disease (PD).

The FDA has approved the Obalon Balloon System (Obalon), a swallowable intragastric gas-filled balloon device, to facilitate weight loss in adults with a body mass index (BMI) of 30-40 kg/m² who have not been able to lose weight through diet and exercise. Two other gastric balloon devices, ReShape and Orbera, were approved earlier.

The FDA has approved the oral tyrosine kinase inhibitor ripretinib (Qinlock – Deciphera) for treatment of adults with advanced gastrointestinal stromal tumors (GISTs) who have previously received treatment with ≥3 kinase inhibitors, including imatinib (Gleevec, and generics).

Fezolinetant (Veozah – Astellas), a first-in-class neurokinin 3 (NK3) receptor antagonist, has been approved by the FDA for treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. It is the second nonhormonal treatment to be approved in the US for this indication; a low-dose formulation of the selective serotonin reuptake inhibitor (SSRI) paroxetine mesylate (Brisdelle) was approved in 2013.

The FDA has approved a 12.45% gel formulation of the anticholinergic drug sofpironium (Sofdra – Botanix) for treatment of primary axillary hyperhidrosis (excessive underarm sweating) in patients ≥9 years old.