FDA Action Alert: Wrapping up 2018 and Heading Into 2019

FDA wording in stamp with red background

With the holidays upon us, along with the end of 2018 and the beginning of 2019, the U.S. Food and Drug Administration (FDA) squeezed some target action dates into the last weeks and beginning of the new year. As it turned out, these appear to be a mixed bag of extensions, resubmissions and supplemental applications, some of which are still pending while others have been approved earlier. Here’s a look.

Merck’s Keytruda … Again … Or Not

By now, everyone seemingly knows that Keytruda (pembrolizumab) is Merck & Company’s anti-PD-1 therapy, otherwise called a checkpoint inhibitor. There are more than 850 ongoing clinical trials using Keytruda in a broad range of cancers and treatment settings. As of October 22, the drug had been approved in 61 countries for second-line recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). Merck had a target action date of December 28, 2018 for its supplemental Biologics License Application (sBLA) for Keytruda in previously treated patients with recurrent or metastatic head and neck squamous cell carcinoma. The application was based on data from the Phase III KEYNOTE-040 clinical trial.

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However, on October 22, the company released significantly improved overall survival data for Keytruda from its Phase III KEYNOTE-048 trial. The company stated at that point, with the data so good, it planned to file an sBLA for Keytruda for a first-line indication based on the KEYNOTE-048 data that will include data from KEYNOTE-040 as supportive data. “Based on these results,” the company stated, “Merck has withdrawn the sBLA for KEYNOTE-040 for KEYTRUDA as a second-line treatment in patients with recurrent or metastatic HNCSC, which was previously assigned a Prescription Drug User Fee Act (PDUFA) or target action date of Dec. 28, 2018.”

Ocular Therapeutix’ Dextenza for Eye Pain after Surgery

Ocular Therapeutix, based in Bedford, Mass., had a target action date of December 28 for its Dextenza (dexamethasone insert) for ocular pain after ophthalmic surgery. This is classified as a resubmission as a class 2 response to the FDA’s July 2017 Complete Response Letter.

On December 3, the FDA approved Dextenza. “We are extremely pleased to announce the approval of Dextenza, coming so soon after our pre-approval inspection and approximately one month ahead of the PDUFA date,” stated Antony Mattessich, Ocular Therapeutix’ president and chief executive officer.”

Portola Pharmaceuticals’ Andexxa Manufacturing Process

Headquartered in South San Francisco, Portola Pharmaceuticals has a target action date of December 31 for its Prior Approval Supplement (PAS) filing for the large-scale Generation 2 manufacturing process for Andexxa (coagulation factor Xa (recombinant), inactivated-zhzo). 

Andexxa was approved on May 3, 2018 under the FDA’s Accelerated Approval pathway. It is the first and only antidote indicated for patients treated with rivaroxaban and apixaban, when anticoagulation is needed to be reversed because of life-threatening or uncontrolled bleeding. What the PAS means is the company was planning significant changes to its manufacturing of the drug, which needed approval by the FDA before it could continue. If accepted and approved, the PAS will let Portola begin a broad commercial launch of Andexxa in the U.S.

Acorda Therapeutics’ Inbrija

On September 13, the FDA extended its review of Acorda Therapeutics’ Inbrija, a form of orally inhaled levodopa therapy for the treatment of symptoms of OFF periods in patients with Parkinson’s disease taking a carbidopa/levodopa regimen. The extension was related to submissions Acorda made in response to FDA requests for more information on chemistry, manufacturing and controls (CMC). Because of the amount of data, the agency classified it as a major amendment and extended the target action date from October 5 to January 5.

However, on December 21, the FDA offered an early approval. The most common treatment for Parkinson’s disease is levodopa, which is currently a generic drug. It improves motor symptoms in Parkinson’s patients, but over time patients experience “off periods,” where symptoms return despite treatment. Inbrija is designed to treat those off periods.

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