Five Potential FDA Approvals to Watch in the Coming Months

The coronavirus disease 2019 (COVID-19) pandemic has caused a backlog in FDA drug approvals, and many experts fear that the pandemic will have a negative effect on drug development.¹

However, a new report published by OptumRx challenges that assumption and argues that although delays have occurred, COVID-19’s impact on drug development has been minimal. Several new and promising drugs are making their way through the FDA pipeline with expected approvals in the fourth quarter of 2020 and the first quarter of 2021, according to OptumRx.¹

Five Drugs to Watch Out For in 2020 Q4 and 2021 Q1

1. Roxadustat (FibroGen, expected FDA decision: December 23, 2020)

Roxadustat is intended to treat anemia, which occurs when there is insufficient hemoglobin in the blood, associated with chronic kidney disease. Approximately 4.8 million people are affected by the condition in the United States. If the drug is approved, it will be the first novel treatment for chronic kidney disease related anemia since 1989. Additionally, roxadustat would offer an oral alternative to the currently available injectable product. A sale price has not yet been established.¹

2. Relugolix (Myovant, expected FDA decision: December 20, 2020)

Relugolix is intended to treat male patients with advanced prostate cancer, the second most common cancer in American men. In 2020, there will be an estimated 192,000 new prostate cancer cases and 33,000 deaths. Relugolix works by blocking the hormone that stimulates testosterone production. Testosterone plays a key role in the growth of prostate cancer tumors and treatment often focuses on reducing levels of the hormone in the body. If approved, it will be the first oral GnRH receptor antagonist for advanced prostate cancer.¹

3.Inclisiran (Novartis, expected FDA decision: December 2020)

Inclisiran is intended to treat elevated low-density lipoprotein cholesterol (LDL-C) in patients with atherosclerotic cardiovascular disease and familial hypercholesterolemia, which is caused by a genetic mutation that impacts the breakdown on LDL-C. More than 29 million people in the United States are living with these conditions, and 22 million are treated with oral lipid lowering therapies. Even though inclisiran is a PCSK9 inhibitor, it is also a small interfering RNA. Although inclisiran is a late entry to the market, it only has to be administered by subcutaneous injection once every 6 months. The 2 other drugs on the market, evolocumab and alirocumab, have to be administered every 2 to 4 weeks.¹

4. Berotralstat (BioCryst Pharmaceuticals, expected FDA decision: December 3, 2020)

Berotralstat is meant to prevent hereditary angioedema (HAE) attacks, which are caused by a genetic defect that causes a biochemical imbalance that releases fluids outside of the blood vessels into surrounding tissues. Approximately 7500 people are treated for HAE in the United States. Berotralstat would be a late comer to a crowded market; however, if approved, it would be the first oral, non-biologic, once-daily treatment. This could provide the drug with an advantage over its competitors, according to OptumRx.¹

5. Lisocabtagene maraleucel (Bristol Meyers Squibb, expected FDA decision: delayed)

Lisocabtagene maraleucel is intended to treat adult patients with diffuse large B-cell lymphoma that has either relapsed or does not respond to treatment after at least 2 prior therapies. An initial decision for the drug was slated for November 16, 2020. However, the FDA was not able to conduct an inspection of a third-party manufacturer facility in Texas due to COVID-19 travel restrictions. Action on the application is being deferred until an inspection can be completed. ¹

Emergency Use Authorizations to Watch out for in 2020 Q4 and 2021 Q1

1. mRNA-1273 COVID-19 vaccine (Moderna Inc)

Moderna announced that its COVID-19 vaccine candidate is 94.1% effective against COVID-19, with a 100% efficacy against severe cases. If approved, 20 million doses will be available in the United States by the end of 2020, with 500 million to 1 billion doses available globally in 2021.²

2. mRNA COVID-19 vaccine (Pfizer Inc)

Pfizer Inc. and BioNTech SE’s COVID-19 vaccine, BNT162b2 is 95% effective against COVID-19. No serious safety concerns were observed to date. If approved, an expected 50 million doses will be available in 2020 and 1.3 billion doses available by the end of 2021.³

REFERENCE:

• OptumRx Drug Pipeline Insights Report [Report] 2020. Accessed December 2, 2020. https://www.optum.com/content/dam/optum3/optum/en/resources/PDFs/3785831-Q4-drug-pipeline-report.pdf.
• Moderna to apply for FDA emergency use authorization for COVID-19 vaccine candidate [article] American Hospital Association, November 30, 2020. Accessed December 2, 2020. https://www.aha.org/news/headline/2020-11-30-moderna-apply-fda-emergency-use-authorization-covid-19-vaccine-candidate.
• PFIZER AND BIONTECH TO SUBMIT EMERGENCY USE AUTHORIZATION REQUEST TODAY TO THE U.S. FDA FOR COVID-19 VACCINE [News Release] November 20, 2020; New York, NY. Accessed December 2, 2020. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-submit-emergency-use-authorization.