On July 24, 2019, the U.S. Food and Drug Administration (FDA) approved Baqsimi™ (glucagon) nasal powder as the first injection-free therapy for the emergency treatment of severe low blood sugar (hypoglycemia) in diabetic patients ages four and older. Hypoglycemia occurs when blood sugar levels drop significantly, resulting in a variety of symptoms with confusion being the most common. It is typically seen in diabetic patients who are using insulin therapy but may also occur if they are taking certain oral medications. In clinical trials involving a total of 201 patients, Baqsimi™, when compared to glucagon injection, was shown to adequately raise blood sugar levels. The approval of Baqsimi™ provides patients an effective new treatment option that can be easily administered into the nose.
On July 26, 2019, the FDA announced the approval of a new boxed warning for an increased risk of blood clots and death for patients taking a 10mg twice daily dose of Xeljanz®/Xeljanz XR® (tofacitinib), which is the approved dose for short term use in patients with ulcerative colitis. In addition, the FDA has restricted the approved use of Xeljanz®/Xeljanz XR® for ulcerative colitis to specific patients who are not adequately treated or cannot tolerate certain other medicines. The new labeling restrictions are the result of an FDA review of interim data from an ongoing safety trial that examined both low dose and high dose regimens of the medicine in patients with rheumatoid arthritis (RA). The announcement is an update to the FDA Drug Safety Communication issued in February 2019 alerting the public of an increased risk for blood clots in the lungs in patients with RA.
On Aug. 12, 2019, results from the first-in-human phase 1 trial of vaccine candidates for chlamydia were published in The Lancet. Chlamydia is the most commonly reported sexually transmitted disease in the U.S., with more than 1.7 million reported cases in 2017. The trial included 35 healthy female participants ranging from 19-45 years old and randomly assigned them to one of three treatment groups, including two variations of the vaccine and placebo. Results of the trial showed that 100% of patients in the treatment groups demonstrated an immune response to the vaccine without serious adverse reactions. Although the trial did not demonstrate chlamydia transmission prevention, the preliminary safety and efficacy of the vaccine candidates confirms promise for further clinical development.
Novel Drug Approval: Turalio™ (pexidartinib)
Oral capsules for the treatment of a rare joint tumor known as a tenosynovial giant cell tumor (TGCT) in adult patients [8/2/2019 – Breakthrough Therapy; Orphan Drug; Priority Review – DAIICHI SANKYO INC]
Novel Drug Approval: Wakix® (pitolisant)
Oral tablets for the treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy [8/14/19 – Orphan Drug; Priority Review – BIOPROJET PHARMA]
Novel Drug Approval: pretomanid
Oral tablets for the treatment of drug-resistant tuberculosis (TB) [8/14/19 – Orphan Drug; Priority Review; Qualified Infectious Disease Product – THE GLOBAL ALLIANCE FOR TB DRUG DEV]
Novel Drug Approval: Rozlytrek™ (entrectinib)
Oral capsules for the treatment of adult patients with lung cancer and solid tumors in patients 12 years and older [8/15/19 – Accelerated Approval; Breakthrough Therapy; Orphan Drug; Priority Review – GENENTECH INC]
As of this issue, there were no new generics entering the marketplace. However, there are several projected generic launches we are monitoring, including:
Emend® (fosaprepitant dimeglumine)
Indication: Nausea and vomiting associated with chemotherapy
Dosage Form/Strength: 115mg, 150mg injection
Projected Launch Date: September 5, 2019
Cystaran® (cysteamine hydrochloride)
Indication: Treatment of amino acid build up in the cornea caused by a rare genetic disorder, cystinosis
Dosage Form/Strength: 0.44% ophthalmic suspension
Projected Launch Date: October 2, 2019