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FDA Action Alert: Mallinckrodt, Kala Pharma, Merck, Eisai and More

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It’s a busy week on the U.S. Food and Drug Administration (FDA)’s calendar, although the agency got ahead of itself and approved three of the applications early. Here’s a look.

Agios Pharmaceuticals had a Prescription Drug User Fee Act (PDUFA) action date of Tuesday, August 21, for its ivosidenib (AG-120) for patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with an isocitrate dehydrogenase 1 (IDH1) mutation. However, the FDA approved this application early, on July 20. The FDA granted the drug Priority Review. The drug is a first-in-class, oral, targeted inhibitor of mutant IDH1. In a related note, Abbott submitted a Premarket Approval (PMA) application for an IDH1 assay on the Abbott 2000 RealTime System, an automated sample preparation and batch analyzer system. Agios and Abbott signed a deal in 2014 where Abbott was responsible for developing and commercializing a RealTime PCR assay for IDH1 mutations in bone marrow and blood, which will act as a companion diagnostic for ivosidenib.

Mallinckrodt Pharmaceuticals has a target action date of Wednesday, August 22 for stannsoporfin for the treatment of neonates at risk for developing severe jaundice (hyperbilirubinemia). The drug received Fast Track status. The drug is a heme oxygenase inhibitor that has the potential to cut the production of bilirubin in infants at risk for jaundice.

Kala Pharmaceuticals has a target action date of Friday, August 24 for Inveltys (KPI-121 1%), a topical twice-a-day treatment for inflammation and pain in patients after ocular surgery. If approved, it will be the first twice-daily ocular corticosteroid for the treatment of postoperative ocular inflammation. All the others are approved four times a day. The compound uses the company’s proprietary Mucus Penetrating Particle (MPP) technology.

Also Friday, August 24, Merck & Co. and Eisai were expecting a response to their supplemental New Drug Application (sNDA) for lenvatinib for the potential first-line treatment of unresectable hepatocellular carcinoma (HCC). This date was an extension from the original date of May 24, as the FDA wanted more time to review the application. They approved the drug a week early, on Friday, August 16. The drug, marketed as Lenvima, is approved in the U.S. for locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer. It has also been approved in the U.S. in combination with everolimus in patients with advanced renal cell carcinoma after one prior anti-angiogenic therapy.

Friday, August 24 is a busy day for the agency. Regeneron Pharmaceuticals is waiting on a supplemental Biologics License Applications (sBLA) for use of Praluent (alirocumab) for use with apheresis. Praluent is a PCSK9 inhibitor for high cholesterol. Apheresis is a nonsurgical procedure that removes low-density lipoprotein (LDL) cholesterol from a patient’s blood.

Shionogi & Co had a PDUFA date of Sunday, August 26 for its NDA for lusutrombopag for treatment of thrombocytopenia in patients with chronic liver disease at increased risk for bleeding associated with invasive procedures. The FDA approved the drug on August 1. The submission was based on two Phase III clinical trials that showed the drug met the pre-specified primary and all key secondary endpoints. The drug also had Priority Review status. Lusutrombopag is an oral, small molecule agonist of the human thrombopoietin receptor. It was approved in 2015 in Japan for the same indication.

Shire also has a PDUFA date of Sunday, August 26. In Shire’s case, it’s for lanadelumab’s BLA for angioedema attacks in patients 12 years and older with the rare, genetic disorder, hereditary angioedema. The FDA also granted the drug Priority Review. Lanadelumab is a fully human monoclonal antibody that specifically binds and inhibits plasma kallikrein.

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Thanasis Chalikias Προβολή όλων

A Product Manager with expertise in pharma marketing and sales operations

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