In 2018, the U.S. Food and Drug Administration (FDA) approved 59 novel drugs, meaning approved new molecular entities (NMEs). The figure for 2017 was 46 novel drugs. The FDA notes, “Each year, CDER [Center for Drug Evaluation and Research] approves a wide range of new drugs and biological products. Some of these products are innovative new products that never before have been used in clinical practice. Others are the same as, or related to, previously approved products, and they will compete with those products in the marketplace.”
BioSpace analyzed new drug approvals from 2014 to 2018 to determine which companies were responsible for the most drug approvals in that period. Here’s a look.
#1. AstraZeneca. From 2014 to 2018, AstraZeneca had nine new drugs approved. In 2014, the agency approved AstraZeneca’s Farxiga, Movantik, and Lynparza. Farxiga is for type 2 diabetes; Movantik is prescribed for opioid-induced constipation; Lynparza is prescribed to treat ovarian and breast cancers. In 2015, the FDA approved AstraZeneca’s Tagrisso. Tagrisso is prescribed to treat specific types of non-small cell lung cancer (NSCLC). They skipped a year, then in 2017, the agency approved the company’s Imfinzi, Calquence and Fasenra. Imfinzi is used to treat NSCLC. Calquence is for mantle cell lymphoma, and Fasenra is used to treat severe eosinophilic asthma. In 2018, the FDA approved Lokelma and Lumoxiti. Lokelma is prescribed to treat hyperkalemia. Lumoxiti is used to treat hairy cell leukemia.
#2. Eli Lilly and Company. In the five-year period, Eli Lilly had eight new drug approvals. Lilly’s Cyramza was approved in 2014, as well as its Trulicity. Cyramza was approved for the treatment of advanced or metastatic gastric cancer or gastroesophageal junction (GEJ) adenocarcinoma. Trulicity is used to treat type 2 diabetes. In the first half of 2018, Trulicity brought in $1.46 billion in sales. In 2015, the FDA approved Portrazza to treat squamous non-small cell lung cancer (NSCLC). In 2016, the agency approved Taltz and Lartruvo. Taltz is used to treat active psoriatic arthritis. Lartruvo is used to treat soft tissue sarcoma (STS). The following year, 2017, the FDA approved Lilly’s Verzenio. Verzenio is used to treat breast cancer. In 2018, Olumiant and Emgality were approved. Olumiant is used to treat rheumatoid arthritis. Emgality is prescribed to treat migraine.
#3. Merck & Company. From 2014 to 2018, the FDA approved seven of Merck’s novel drugs. In 2014, the FDA approved Merck’s Belsomra and Keytruda. Belsomra is a sleep medication. Keytruda, of course, is Merck’s checkpoint inhibitor that has been approved for a broad range of cancer indications. In 2017, Keytruda brought in more than $3.8 billion. There were no approvals in 2015, but in 2016, Merck’s Zepatier and Zinplava were approved. Zepatier is used to treat hepatitis C. Zinplava is used to treat Clostridium difficile infection. The FDA approved Prevymis and Steglatro in 2017, and Pifeltro in 2018. Prevymis is used to prevent cytomegalovirus (CMV) infection. Steglatro is prescribed for type 2 diabetes. Pifeltro is used to treat HIV.
#4.(T) Genentech. Over this period, Genentech, a Roche company, had six novel drugs approved by the FDA. The first approval, in 2014, was for Esbriet, for idiopathic pulmonary fibrosis (IPF). In 2015, the FDA approved Cotellic, which is used with Zelboraf to treat melanoma. In 2015, Tecentriq was approved for non-squamous NSCLC and bladder cancer. Tecentriq is an anti-PD-L1 checkpoint inhibitor. In 2017, the FDA approved Ocrevus for multiple sclerosis (MS) and Hemlibra for hemophilia A. In 2018, Genentech’s Xofluza was approved to treat influenza. As a side note, in 2015, the FDA approved Roche’s Alecensa to treat NSCLC.
• Alecensa (Roche)
#4.(T) Gilead Sciences. Like Genentech, Gilead had six novel drugs approved by the FDA from 2014 to 2018. The FDA approved Gilead’s Zydelig and Harvoni in 2014. Zyedelig is prescribed for relapsed follicular lymphoma, chronic lymphocytic leukemia and small lymphocytic lymphoma. Harvoni is used to treat hepatitis C. A year later, the agency approved Gilead’s Genvoya, a four-drug combination for hepatitis B (HBV). In 2016, Epclusa, a two-drug combination for HCV, was approved. The FDA approved Vosevi in 2017 for HCV. And in 2018, FDA approved Biktarvy for HIV. Gilead’s HCV treatments have been so good, they essentially cure the disease, which has led to falling sales as the patient population decreases. Good for patients, not so good for the company. In a three-year period, Gilead’s flagship HCV drugs brought in more than $44 billion.
#4(T). Novartis. Novartis ties with Genentech and Gilead Sciences, having had six new drugs approved in the five-year period. 2014 marked the approval of Zykadia for NSCLC. In 2015, the FDA approved Cosentyx, Farydak and Entresto. Cosentyx is used to treat plaque psoriasis, psoriatic arthritis and ankylosing spondylitis. Farydak is for the treatment of multiple myeloma. Entresto is used to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure. The agency approved Kisqali for breast cancer and Rydapt for acute myeloid leukemia in 2017
Rounding out the top 12, Allergan, Janssen (a division of Johnson & Johnson), and Pfizer all had five drugs approved in the five-year period. After those three, AbbVie, Amgen and Boehringer Ingelheim followed, each of the companies having four drugs approved between 2014 and 2018.
A Product Manager with expertise in pharma marketing and sales operations