By Paula Burkes
Copyright © 2017, The Oklahoma Publishing Company
Q: Last year, the Food and Drug Administration approved 22 new drugs. How does that compare to past years?
A: It’s a sharp drop-off from 2016, when we saw twice as many new drugs reach the market. Over the previous five years, the FDA had approved an average of 36 new drugs a year, so this was a big step back. It’s the lowest number we’ve seen since 2010.
Q: What drove this plunge?
A: Drug approvals tend to swing from year to year. The class of 2015 included five drugs that weren’t supposed to receive a thumbs up or down from the FDA until 2016, but the approval process was accelerated for them. So that simultaneously inflated the numbers for 2015 and deflated the 2016 figures. We also had a decline in the number of new drug applications filed for approval, and the FDA rejected or delayed more applications than in the previous two years.
Q: What does this mean going forward?
A: I suspect this downturn is just a blip. Some of the drugs that were delayed still stand a good chance of winning approval in 2017, including new treatments for multiple sclerosis and rheumatoid arthritis. We’ve seen a steady stream of new breakthroughs in using the body’s own immune system to fight cancer, and our understanding of the genetics of many diseases has improved vastly. As a result, the developmental pipelines of biotech and pharmaceutical companies are filling. I hope that means we’ll experience a bounce in coming years.
Q: Were there any blockbusters that hit the market last year?
A: No. Probably the biggest new drug was Roche’s Tecentriq, a so-called immunotherapy drug that carries a price tag of about $12,500 a month. It was initially approved to treat bladder cancer, and the FDA subsequently OK’d its use for lung cancer. The drug will likely gain approval as a therapeutic for other cancers, as well, and as a result, analysts are projecting that annual revenues will reach $4 billion by 2021. Still, we didn’t see anything along the lines of Gilead’s hepatitis C treatments, Sovaldi and Harvoni, which came on the markets in 2013 and 2014 and generated $19 billion in combined sales last year.
Q: How about Alzheimer’s drugs?
A: I wish I had better news to report. The biggest development on this front came in November, when an experimental drug that had previously appeared to show promise failed a clinical trial in 2,100 patients with mild dementia. Still, Eli Lilly is continuing to test the drug, solanezumab, in hopes that it may help stave off the disease in people who are at high risk for Alzheimer’s. Trials also continue with a number of other investigational drugs, some of which target amyloid (the protein that makes up the plaques characteristic of the disease), while others try to block an enzyme known as BACE that makes a protein needed for amyloid production.
Q: Looking ahead, what’s the biggest issue facing the drug industry?
A: Pricing. A firestorm ignited over the cost of EpiPens, the lifesaving anti-allergy injector whose price rose almost sixfold from 2008 to 2016. But that’s just the tip of the iceberg. With some disease therapies now costing upward of a half-million dollars per year, insurers are increasingly limiting access to expensive drugs. Something has to give. Perhaps President-elect Trump, who has vowed to bring down drug prices, can strike the balance that has so far eluded us: encouraging manufacturers to continue to develop innovative new drugs while ensuring that all Americans have access to them.
PAULA BURKES, BUSINESS WRITER
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