FDA Updates: Moderna COVID-19 Vaccine EUA Caps Busy Week

Moderna vaccine ships after emergency authorization. The first doses of Moderna’s coronavirus disease 2019 (COVID-19) vaccine shipped early Sunday from a McKesson distribution facility in Olive Branch, Mississippi, following FDA’s action Friday on the second emergency use authorization (EUA) for a vaccine. The Moderna EUA came almost exactly a week after the first one, for Pfizer’s vaccine, which also followed a positive vote from an FDA advisory panel. Like the Pfizer-BioNTech vaccine, the Moderna product uses mRNA technology, but it does not require the extreme level of refrigeration to prevent spoilage, which should allow its use in pharmacies and in remote parts of the country. The Moderna vaccine is also given in two doses, but the booster is given 28 days after the first shot, not 21 days, the span required for the Pfizer vaccine. The Moderna vaccine is authorized for persons aged 18 years or older. Authorization came as the nation’s death toll topped 313,000 deaths. Separately, the FDA granted an EUA for the first over-the-counter diagnostic test for COVID-19, developed by Ellume, for persons age 2 years or older.

Orgovyx approved in advanced prostate cancer. FDA on Friday approved Myovant Sciences’ Orgovyx (relugolix), an oral gonadotropin-releasing hormone antagonist for the treatment of advanced prostate cancer. Data from the phase 3 HERO trial presented at the American Society of Clinical Oncology (ASCO) supported the application, and showed that the drug achieved its primary endpoint of sustained testosterone suppression to castrate levels (< 50 ng/dL) through 48 weeks in 96.7% of men, compared with 88.8% of men receiving standard of care. Within 90 days of treatment, 55% of men treated with Orgovyx achieved normal testosterone levels. Serious adverse events (AEs) occurred in 12% of patients; fatal and non-fatal heart attack and stroke were reported in 2.7% of patients taking the drug. Prostate cancer accounts for the second-highest number of cancer deaths among US men and has the largest racial disparity of any major cancer.

New indication for Iclusig in CP-CML. Also Friday, Takeda announced FDA approval for its supplemental New Drug Application (sNDA) for Iclusig (ponatinib) for adult patients with chronic phase chronic myeloid leukemia (CP-CML), who have resistance or intolerance after trying at least two other kinase inhibitors, or TKIs. Iclusig’s new label includes an optimized, response-based dosing regimen in CP-CML, beginning with 45 mg daily and reducing to 15 mg over time. Patients with this condition often have unmanageable, resistant disease and if they are intolerant to earlier generation TKIs their prognosis is poor. CP-CML is often manageable, but patients who are resistant or intolerant to earlier-generation TKIs experience poor long-term outcomes. Iclusig is the only approved third-generation, and only pan-mutational, TKI designed to deliver a potency dose against uniquely designed to confer high potency against BCR-ABL1, a gene sequence found in an abnormal chromosome 22 in some forms of leukemia. Approval was based on phase 2 results of the OPTIC trial, with data presented over the past year at ASCO and the recent meeting of the American Society of Hematology.

Extended review for roxadustat. Friday also brought an announcement that FDA had extended until March 20, 2021, the review period for the NDA for roxadustat for the treatment of anemia of chronic kidney disease (CKD). The announcement said the FDA is close to finalizing its review and sponsor FibroGen is submitting additional analyses of existing roxadustat clinical data, which require an extension of the original target action date under the Prescription Drug User Fee Act. Roxadustat is an oral small molecule hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor, the first of its class accepted by the FDA for review for the treatment of anemia of CKD.