Since March of last year, one of the FDA’s top priorities has been approvals related to COVID-19. While that is still true for this year, they have also been working on approvals of non-COVID related drugs. Innovation drives progress. When it comes to innovation in the development of new drugs the FDA’s Center for Drug Evaluation and Research (CDER) supports the pharmaceutical industry at every step of the process. The availability of new drugs and biological products often means new treatment options for patients and advances in health care for the American public. Below is a list of the newly approved drugs, for 2021.
- Verquvo – January 19
Verquvo is the first soluble guanylate cyclase stimulator to be approved to treat heart failure. It has been approved to reduce the risk of cardiovascular death and heart failure hospitalization following a hospitalization for heart failure or need for outpatient intravenous (IV) diuretics in adults with symptomatic chronic heart failure and ejection fraction less than 45%.
- Cabenuva – January 21
Cabenuva is the first and only complete long-acting regimen for HIV treatment. Cabenuva is provided as a co-pack with two injectable medicines — ViiV Healthcare’s cabotegravir and Janssen’s rilpivirine — dosed once monthly, as an option to replace the current antiretroviral (ARV) regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per milliliter [mL]) on a stable regimen, with no history of treatment failure, and with no known or suspected resistance to either cabotegravir or rilpivirine.
- Lupkynis – January 22
Lupkynis is the first FDA-approved oral therapy for lupus nephritis (LN) in combination with a background immunosuppressive therapy regimen. In pivotal trials, patients treated with Lupkynis in combination with standard-of-care (SoC) were more than twice as likely to achieve renal response and experienced a decline in urine protein creatinine ratio (UPCR) twice as fast as patients on typical SoC alone.
- Tepmetko – February 3
Tepmetko has been approved by the FDA for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations. Tepmetko is the first and only FDA approved MET inhibitor that offers once-daily oral dosing and is administered as two 225 mg tablets (450 mg).
- Ukoniq – February 5
Ukoniq had been approved for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20 based regimen and adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least three prior lines of systemic therapy. It is the first and only, oral, once daily, inhibitor of phosphoinositide 3 kinase (PI3K) delta and casein kinase 1 (CK1) epsilon.
- Evkeeza – February 11
Evkeeza is FDA approved as an adjunct to other low-density lipoprotein cholesterol (LDL-C) lowering therapies to treat adult and pediatric patients aged 12 years and older with homozygous familial hypercholesterolemia (HoFH). Evkeeza is the first FDA-approved treatment that binds to and blocks the function of angiopoietin-like 3 (ANGPTL3), a protein that plays a key role in lipid metabolism.
- Cosela – February 12
Cosela is the only FDA-approved injection to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer (ES-SCLC). It is the first and only therapy designed to help protect bone marrow (myeloprotection) when administered prior to treatment with chemotherapy.
For drug approval for 2020 and previous years, check out the FDA website and learn more about each of them.