Drugs with March PDUFA Dates

The FDA has several drugs with PDUFA Dates in March. One was approved earlier this week and six more have PDUFA Dates coming up in the coming days.

On March 5, 2019 the FDA approved esketamine nasal spray, in conjunction with an oral antidepressant, for the treatment of resistant depression. The labeling for esketamine nasal spray contains a Boxed Warning describing a risk for sedation and difficulty with attention, judgment and thinking (dissociation), abuse and misuse, and suicidal thoughts and behaviors. The drug is only available through a restricted distribution system, under a Risk Evaluation and Mitigation Strategy (REMS). Esketamine must be administered in a certified medical office where the health care provider can monitor the patient for a minimum of 2 hours and determine when the patient can leave. The patient also needs transportation to and from the visit for a dose because they are unable to drive until the day after a dose. Since the patient cannot take the spray home, the treatment sites will need to determine where patients will wait during the monitoring period and coordinate patient visit to avoid a slowdown in office workflow. WAC for esketamine nasal spray is $590 to $885 per treatment session. The drug is dosed twice a week for the initial 4 weeks, so the monthly cost will be $4,720 to $6,785. Esketamine nasal spray is dosed once weekly during the second month ($2,360 to $3,540). In the third month the patient may continue weekly dosing or have their dosing further reduced to every other week, so the WAC price for maintenance dosing is $1,180 to $3,540.

​Drug with upcoming PDUFA Dates in March

• Aerie Pharmaceuticals’ combination ophthalmic netarsudil mesylate and latanoprost has a PDUFA date of March 14 for the treatment of glaucoma.
• Sage Therapeutics’ has a March 19, 2019 PDUFA for its GABA modulator brexanolone being developed for the treatment of postpartum depression. Brexanolone has orphan drug and breakthrough therapy priority designations.
• Jazz Pharmaceuticals has a March 20 PDUFA date for Solriamfetols it’s selective norepineprhine and ropamine Reuptake Inhibitor being developed for the treatment of excessive sleepiness in narcolepsy and obstructive sleep apnea. The FDA had delayed the PDUFA date for solriamfetol by three months. Solriamfetol has an orphan drug priority designation.
• Sanofi has a March 22 PDUFA date for sotagliflozin, a SGLT-1 and SGLT-2 being developed for the treatment of Type 1 and Type 2 diabetes.
• AMAG has a March 23 PDUFA date for its melanocortin 4 receptor agonist, bremelanotide for the treatment of hypoactive sexual desire disorder.
• Novartis has a March 31, 2019 PDUFA date for a decision on siponimod, its sphingosine-1-phosphate receptor modulator being developed for the treatment of relapsing/remitting multiple sclerosis and secondary progressive multiple sclerosis.