FDA Review: Abiomed, Mallinckrodt, Aro and More

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The FDA has a broad range of activities in the drug and medical device space. Here’s a look at the agency’s work this week.

September 16

Abiomed reported the FDA approved the on-label RECOVER IV trial in AMI cardiogenic shock patients. The agency also approved and closed Impella’s prospective AMI cardiogenic shock post-approval study, RECOVER III.

September 15

Mallinckrodt announced the FDA approved Terlivaz (terlipressin) for injection to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function.

Aro Biotherapeutics was granted Rare Pediatric Drug (RPD) designation for ABX1100 for the treatment of Pompe disease.

Kymera Therapeutics’ KT-333 received Orphan Drug Designation for the treatment of cutaneous T-cell lymphoma (CTCL).

20/20 Imaging, a division of Konica Minolta Healthcare Americas received FDA clearance of the Chiropractic Straight Arm (CSA) system with Dynamic Digital Radiography (DDR). It allows for visualization of anatomy in motion.

Inversago Pharma received clearance to launch a Phase II trial of INV-202, a a small molecule CB1 inverse agonist/antagonist, for diabetic kidney disease.

Jasper Therapeutics’ JSP191 received Fast Track Designation for the treatment of patients with severe combined immunodeficiency (SCID) undergoing allogeneic hematopoietic stem cell transplant. The drug is an anti-CD117 monoclonal antibody.

September 14

TRACON Pharmaceuticals received Fast Track Designation for envafolimab, a single-domain antibody against PD-L1 licensed by TRACON from Alphamab Oncology.  The designation is for soft tissue sarcoma subtypes of locally advanced, unresectable or metastatic undifferentiated pleomorphic sarcoma and myxofibrosarcoma.

Aldeyra Therapeutics reported it had received the official minutes from its pre-NDA meeting with the FDA. It is on schedule to submit the NDA in the fourth quarter for the novel RASP modulator reproxalap for dry eye disease.

Revive Therapeutics submitted an amended Phase III COVID-19 trial protocol to the FDA to evaluate Bucillamine in mild to moderate COVID-19.

Transcenta Holding Limited announced the FDA cleared its TST003, a first-in-class, high affinity humanized monoclonal antibody targeting Gremlin1, for a Phase I trial.

Tasso’s Tasso+ lancet was cleared by the FDA as a Class II medical device. This allows Tasso to market and sell to more customers across the U.S.

September 13

Marker Therapeutics received a $2 million grant from the FDA Orphan Products Grants program in support of its Phase II ARTEMIS trial of MT-401 in patients with post-transplant acute myeloid leukemia.

SetPoint Medical stated the FDA approved continuation of its RESET-RA trial, which received an Investigational Device Exemption (IDE) to evaluate patients with rheumatoid arthritis in January 2021.

Otsuka and H. Lundbeck A/S announced the FDA accepted their New Drug Application for aripiprazole for the treatment of schizophrenia in adults and for maintenance monotherapy of bipolar I disorder in adults.

Akouos received clearance to initiate a Phase I/II pediatric clinical trial of its gene therapy AK-OTOF for otoferlin gene-mediated hearing loss.

Potrero Medical reported the FDA granted Breakthrough Device Designation for its AKI Predict machine learning algorithm for the purpose of predicting acute kidney injury associated with intra-abdominal hypertension in cardiac post-surgical intensive care patients.

aTyr Pharma's efzofitimod received Fast Track Designation for the treatment of systemic sclerosis (SSc)-associated interstitial lung disease.

September 12

BioLineRx submitted an NDA to the FDA for motixafortide in stem cell mobilization for autologous bone marrow transplantation for multiple myeloma patients.

Ocuphire Pharma was granted a small business waiver of the $3.1 million PDUFA fee for the 505(b)(2) NDA for Nyxol (phentolamine ophthalmic solution).

CurveBeam AI announced its medical diagnostic software, OssView, received Breakthrough Device Designation. OssView calculates a Structural Fragility Score (SFS), which determines the deterioration of bone microstructures.

Acadia Pharmaceuticals’ NDA for trofinetide for Rett syndrome was granted priority review and assigned a PDUFA date of March 12, 2023.

Mersana Therapeutics received Fast Track Designation for XMT-1660 to treat triple-negative breast cancer.