Regeneron and Sanofi's competitor, Amgen, announced Tuesday its trial assessing cardiovascular effects of the drug in 27,500 patients had been fully enrolled.
Amgen's medicine, Repatha, is being discussed Wednesday by the panel.
The company may have a leg up on its competition given Amgen looks to be about six months ahead of Regeneron on enrollment, said Deutsche Bank analyst Robyn Karnauskas.
Beyond concerns about the feasibility of conducting the trials, the drugmakers are incented to complete them in order to secure better reimbursement for the medicines, Nissen said.
Analysts estimate they may cost $10,000 per year, as new, branded, biologic drugs given by injection. By contrast, statins are in many cases generic, and given by pill. Already pharmacy benefits managers like Express Scripts and CVS Health have raised red flags about the new medicines' costs.
But most importantly, Nissen said, are the effects the drugs could have on public health. He said he's confident the medicines, known as PCSK9 inhibitors, will have a major impact on cardiovascular disease, given their mechanism is well understood, and noted the safety profile looks clean.
"Keeping these drugs from the market and denying patients who have this much need access to a really innovative and powerful class of drugs for three or four more years is just not in the public interest," Nissen said. "It's important to understand these drugs are not being used to treat skin rashes, they're being used to treat the leading cause of death amongst men and women in the U.S. and most developed countries."
The drugs are expected to be approved by the FDA this summer. The regulator often follows the advice of its outside panel, but doesn't have to. A vote on Amgen's medicine is expected late afternoon Wednesday.