Home 9 Latest News 9 FDA Drug Approval Decisions Expected in July 2024

FDA Drug Approval Decisions Expected in July 2024

June 21, 2024

The PDUFA date refers to the deadline set by the US Food and Drug Administration for reviewing drug applications.
The Prescription Drug User Fee Act (PDUFA) date refers to the deadline set by the US Food and Drug Administration (FDA) for reviewing a New Drug Application (NDA) or Biologics License Application (BLA) and making a final decision on marketing approval. The typical period for review is 10 months after the drug application has been accepted by the Agency. For drugs that have Priority Review, the review period is reduced to 6 months from the time of application acceptance.

Roflumilast Cream 0.15% for Atopic Dermatitis
PDUFA date: July 7, 2024
The FDA is reviewing the supplemental NDA for roflumilast cream 0.15%, a phosphodiesterase 4 inhibitor, for the treatment of atopic dermatitis. The sNDA is supported by data from the phase 3 INTEGUMENT-1 (ClinicalTrials.gov Identifier: NCT04773587) and INTEGUMENT-2 (ClinicalTrials.gov Identifier: NCT04773600) trials, which evaluated the efficacy and safety of roflumilast cream 0.15% in patients 6 years of age and older with mild to moderate atopic dermatitis involving at least 3% body surface area.

The primary endpoint of the study was Investigator Global Assessment (IGA) success, defined as a validated Investigator Global Assessment – Atopic Dermatitis score of ‘clear’ or ‘almost clear’ plus a 2-grade improvement from baseline at week 4.

In INTEGUMENT-1 (N=654), 32% of patients treated with roflumilast cream achieved IGA success vs 15.2% of patients who received vehicle (P <.0001), while in INTEGUMENT-2 (N=683), 28.9% of roflumilast-treated patients met the primary endpoint compared with 12% of the vehicle group (P <.0001).

Roflumilast has already been approved in a 0.3% cream formulation for plaque psoriasis and a 0.3% topical foam for seborrheic dermatitis.

High-Dose Naloxone for Opioid Overdose
PDUFA date: July 15, 2024
OX124 is an intranasal product that contains a high-dose of naloxone, an opioid antagonist that reverses the effects of opioids, including respiratory depression, sedation, and hypotension. Using Orexo’s proprietary technology, OX124 is expected to reverse opioid overdoses from highly potent synthetic opioids, such as fentanyl.

The NDA submission includes data from a clinical study that showed use of OX124 in healthy volunteers led to significantly faster and higher absorption of naloxone compared with intramuscular injection of another naloxone product.

A Prescription User Fee Act date of July 15, 2024 has been set for the application, though Orexo noted that the regulatory decision may be delayed.

Vonoprazan for Heartburn Associated With Nonerosive GERD
PDUFA date: July 19, 2024
The FDA is reviewing the NDA for vonoprazan for the treatment of heartburn associated with nonerosive gastroesophageal reflux disease (NERD) in adults. Vonoprazan is an oral small molecule potassium-competitive acid blocker.

The NDA is supported by efficacy and safety data from the phase 3 PHALCON-NERD-301 study (ClinicalTrials.gov Identifier: NCT05195528), which included 772 adults with symptomatic NERD. The primary endpoint was the percentage of days without daytime or nighttime heartburn at week 4.

Findings showed a significantly greater percentage of 24-hour heartburn-free days with both doses of vonoprazan compared with placebo (mean 45% for 10mg, 44% for 20mg vs 28% for placebo; P <.0001).

Vonoprazan is currently marketed under the brand name Voquezna for healing and maintenance of healing of all grades of erosive esophagitis, and relief of heartburn associated with erosive esophagitis in adults. It is also approved in combination with amoxicillin, with or without clarithromycin, for the treatment of H. pylori infection in adults.

ALPHA-1062 for Mild to Moderate Alzheimer Disease
PDUFA date: July 27, 2024
ALPHA-1062 is a prodrug of the acetylcholinesterase inhibitor, galantamine, an approved therapy for mild to moderate Alzheimer disease. According to Alpha Cognition, the investigational agent was designed to reduce the gastrointestinal side effects observed with galantamine while also increasing its bioavailability.

The NDA submission includes data from 4 studies demonstrating bioequivalence for ALPHA-1062 to galantamine and galantamine ER. In a pivotal bioequivalence study, results showed ALPHA-1062 achieved bioequivalent area-under-the curve (AUC) and peak exposures relative to the immediate-release formulation of galantamine.

Similar findings were observed in a study comparing ALPHA-1062 to a delayed-release formulation of galantamine. Findings showed ALPHA-1062 achieved AUC and peak exposures of approximately 107% and 127%, respectively, compared with those generated by galantamine hydrobromide ER.



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