FDA Weekly Review: Daewoong, Novavax, Preceptis and More


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The FDA is busy accepting drug applications, granting specialty designations and approving drugs for market. Here's a look at this week's FDA activity.

Daewoong Pharmaceutical Co. announced that the FDA cleared its Investigational New Drug (IND) application to launch a Phase I trial of DWP213388 for autoimmune diseases. The drug is a dual-target inhibitor for both B and T cells, inhibiting BTK and Interleukin-2-inducible T-cell Kinase (ITK).

Novavax submitted an application to the FDA for an Emergency Use Authorization (EUA) for its COVID-19 vaccine as a booster in adults 18 and older. An original EUA was granted in July for the vaccine as a two-dose initial series.

Preceptis Medical said the FDA cleared its Hummingbird Tympanostomy Tube System (TTS) for office-based pediatric ear tube procedures. The new label allows for in-office procedures in all children six months and older.

NovelMed Therapeutics received clearance from the FDA to initiate an efficacy trial of NM8074 in patients with C3G, a rare disease characterized by the deposition of Cd/C3b on kidney cells, proteinuria, and reduced eGFR. The drug is a monoclonal antibody that binds Bb with picomolar affinity and exhibits dual specificity.

VySpine reported the FDA granted 510(k) clearance for its VyPlate Anterior Cervical Plate System, which is indicated for stabilization of the anterior cervical spine from C2 to C7, employing unicortical screw fixation at the anterior face of the vertebral bodies. 

AstraZeneca and Merck announced the FDA accepted and granted priority review for their supplemental New Drug Application (sNDA) for Lynparza in combination with abiraterone and prednisone or prednisolone for adults with metastatic castration-resistant prostate cancer. There is a PDUFA date in the fourth quarter of this year.

The FDA finalized a ruling that hearing aids can be sold over the counter to patients with mild to moderate hearing impairment. No physician prescription or device fitting is required. It only applies to patients 18 years and older.

Bluebird bio announced the FDA approved Zynteglo (betibeglogene autotemcel) for adults and children with beta-thalassemia who require regular RBC transfusions. The therapy is a cell-based gene therapy.

Thermo Fisher Scientific received clearance of ImmunoCAP Specific IgE Allergen Components for wheat and sesame allergies for in vitro diagnostic use. These are advanced blood tests to help ID wheat and sesame allergies.

AVAVA reported that the FDA granted 510(k) clearance for treating benign pigmented skin lesions, including hyperpigmentation. The technology approved is an AI enabled, precise 3D laser treatment.

Samsung Bioepis and Organon & Co. announced the FDA approved the citrate-free, high-concentration formulation of Hadlima (adalimumab-bwwd), a biosimilar to AbbVie's Humira (adalimumab).

AUM Biosciences' AUM601 received Orphan Drug Designation from the FDA for solid tumors with the NTRK fusion gene. AUM601 is a highly selective, oral small molecule that inhibits the pan-TRK (TRKA, TRKB, and TRKC), but also resistance mutations of TRKs by blocking the activity of tyrosine kinases.

Spectral Medical's wholly-owned subsidiary Dialco Medical's Investigational Device Exemption (IDE) received approval by the FDA for up to 10 new clinical sites in its pivotal Tigris trial.

Curis announced the FDA lifted the partial clinical hold on the TakeAim Lymphoma Phase I/II trial of emavusertib. The company now expects preliminary data in 2023.

Zavation Medical Products received FDA 510K clearance of Varisync, a cervical intervertebral body fusion device.

GenFleet Therapeutics received a greenlight from the FDA for its Phase II trial of GFH312 for patients with peripheral artery disease and intermittent claudication. GFH312 is a RIPK1 inhibitor and blocks the process of TNF-alpha-induced necroptosis.

Bayer announced the FDA approved an sNDA that extends the duration of use for its intrauterine device (IUD) Mirena (levonorgestrel-releasing intrauterine system) 52 mg by one more year. This will make it available to prevent pregnancy for up to eight years.

Axsome Therapeutics announced the FDA approved its Auvelty (dextromethorphan HBr-bupropion HCl) for major depressive disorder (MDD) in adults. 

Calyptus Pharmaceuticals received FDA approval for its Abbreviated NDA (ANDA) for an AP-rated generic version of Cetrotide to Calyptus' partner, Akorn Operating Company. The FDA also granted its Competitive Generic Therapy (CGT) designation. Cetrotide is used to treat infertility.

IMPACT Therapeutics' fixed-dose combination of Senaparib (PARP inhibitor) and temozolomide (TMZ) for adults with small cell lung cancer received Orphan Drug Designation from the FDA.

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