Biogen to Present Positive Phase 2 Systemic Lupus Erythematosus Data at American College of Rheumatology 2020 Meeting
In Phase 2 LILAC study, BIIB059 demonstrated a statistically significant reduction in joint disease activity compared to placebo in systemic lupus erythematosus patients
Positive results build on previously reported cutaneous lupus erythematosus data and underscore Biogen’s commitment to the lupus community
Systemic lupus erythematosus is a chronic and debilitating autoimmune disease that affects multiple organ systems, with periods of illness or flares alternating with periods of remission
CAMBRIDGE, Mass., Nov. 03, 2020 (GLOBE NEWSWIRE) — Today, Biogen Inc. (Nasdaq: BIIB) announced positive data from the 24-week systemic lupus erythematosus (SLE) portion of the Phase 2 LILAC study (part A) demonstrating that BIIB059 (anti-BDCA2) was associated with a statistically significant reduction in total active joint count. The study evaluated the efficacy and safety of BIIB059, a humanized IgG1 monoclonal antibody (mAb) targeting blood dendritic cell antigen 2 (BDCA2) expressed exclusively on plasmacytoid dendritic cells. These data, along with the previously reported findings from the cutaneous lupus erythematosus (CLE) portion of the LILAC study, will be presented at the American College of Rheumatology’s ACR Convergence 2020, being held virtually from November 5-9, 2020.
“People living with systemic lupus erythematosus suffer from chronic and debilitating symptoms that impact multiple organ systems as well as their social and emotional well-being,” said Nathalie Franchimont, M.D., Ph.D., Vice President and Head of the Multiple Sclerosis and Immunology Development Unit at Biogen. “These latest data highlight the potential of BIIB059 to impact disease activity and, together with the earlier cutaneous lupus erythematosus findings, reflect Biogen’s commitment to drive therapeutic innovation for lupus patients who have limited treatment options.”
The Phase 2 LILAC study (part A) met its primary endpoint of reducing joint disease activity in individuals with SLE, as measured by total active joint count. A statistically significant difference in change from baseline of 3.4 in total active joint count was observed at week 24 between participants who received BIIB059 450 mg administered subcutaneously every 4 weeks with an additional dose at week 2 versus placebo (p=0.037). Total active joint count is the total number of tender or swollen joints. Tender or swollen joints are one of the most common symptoms impacting quality of life in people living with SLE.
The study also met the secondary endpoint of SLE Responder Index-4 (SRI-4), resulting in an overall reduction in disease activity in participants who received BIIB059 versus placebo. There was a 26.35 percent higher SRI-4 response rate among participants who received BIIB059 (56.77 percent) versus placebo (30.42 percent [odds ratio=3.49, p=0.003]). The SRI-4 is a composite measure comprising criteria from different internationally validated indices of systemic disease activity.
An additional secondary endpoint from part A of the study in individuals with SLE evaluated the effect of BIIB059 on skin disease activity using the CLE Activity Disease Area and Severity Index-Activity (CLASI-A) score in a subgroup of participants with a baseline CLASI-A score of ≥8. There was a 20 percent higher response rate among participants who received BIIB059 (69.10 percent) versus placebo (49.10 percent) who achieved at
Pressure to create a coronavirus vaccine is increasing by the day, but for a safe vaccine to enter the market, it takes time.
A normally backwater committee meeting of a Food and Drug Administration advisory group held Thursday highlighted the extreme importance of getting COVID-19 vaccines right.
The meeting was unlike others held by the Vaccines and Related Biological Products Advisory Committee, a group of outside experts who advise FDA on whether or not to approve drugs, therapeutics and vaccines after they have gone through FDA’s rigorous approval process.
Thursday’s meeting featured excruciatingly detailed presentations by FDA and Centers for Disease Control and Prevention on what’s known about COVID-19 and what requirements must be met for a vaccine to be approved.
The question of when to approve a vaccine is of enormous importance. It must be both safe and effective because it will be given to healthy individuals.
At the same time, as Marion Gruber, director of CDC’s office of Vaccines Research & Review noted, 700 Americans are dying of COVID-19 each day.
Some have been concerned an emergency use authorization (EUA) for a COVID-19 vaccine may mean the vetting process for the vaccine won’t be as thorough as the FDA’s usual licensing process.
By the time agency officials finished their presentations, committee members seemed to be less worried.
“I’m reassured,” said Dr. Paul Offit, a committee member, director of the Vaccine Education Center and an attending physician at Children’s Hospital of Philadelphia. The EUA process FDA described was “much much much closer” to the full licensing process than he had thought, he said.
The committee did not vote on a specific vaccine Thursday but discussed FDA’s guidance and requirements to seek either a license or an emergency use authorization for one.
VRBPAC (pronounced verb-pack) meetings are generally little-noticed outside of pharmaceutical circles but Thursday’s meeting was closely watched and heavily attended online as the committee discussed COVID-19 vaccines. It was streamed live from FDA’s website.
The 15 committee members — all distinguished physicians, scientists and doctors — discussed FDA’s current guidance to COVID-19 vaccine manufacturers and what kinds of data they hope to see when Phase 3 clinical trials for each vaccine are completed.
Generally, the committee meets once FDA has approved a drug or a vaccine. It goes over the application and votes whether it also thinks it should be approved.
FDA officials have said that once a COVID-19 vaccine or vaccines have been presented to the agency for approval — which will not happen for several weeks or months — it will ask the committee to consider the applications.
Thursday’s meeting allowed the group to give feedback to FDA in the middle of the complex and very rapid COVID-19 vaccine development and testing press.
“Note how FDA mentioned several times that an EUA vaccine could reach millions — FDA wants to be real sure it does due diligence,” said John Grabenstein, general manager of Vaccine Dynamics and editor for the Immunization Action Coalition.
President TrumpDonald John TrumpMore than 300 military family members endorse Biden Five takeaways from the final Trump-Biden debate Biden: ‘I would transition from the oil industry’ MORE has not been to a White House coronavirus task force meeting in several months, Anthony FauciAnthony FauciTrump, Biden clash over coronavirus response, mounting death toll Stahl tells Pence he and Trump ‘insulted 60 Minutes’ by giving ‘campaign speeches’ How Trump lost to the coronavirus MORE said Friday.
During an interview on “Meet the Press Daily,” the nation’s top infectious disease doctor said he hasn’t directly interacted with or spoken to Trump in some time.
“I definitely don’t have his ear as much as Scott Atlas right now, that has been a changing situation,” Fauci said.
Scott Atlas is a neuroradiologist and a fellow at the Hoover Institution, a conservative think tank. He was added to the task force over the summer after appearing frequently on Fox News.
Atlas has emerged as one of Trump’s most influential advisers, but he has come under fire from public health experts inside and outside the administration who accuse him of feeding the president — and the public — misinformation.
Fauci said he meets virtually with the heads of federal health agencies, such as Centers for Disease Control and Prevention Director Robert Redfield, Food and Drug Administration Commissioner Stephen Hahn, as well as task force coordinator Deborah BirxDeborah BirxScott Atlas: Fauci ‘just one person on the task force’ Overnight Health Care: Trump takes criticism of Fauci to a new level | GOP Health Committee chairman defends Fauci | Birx confronted Pence about Atlas Birx confronted Pence about Atlas MORE.
Fauci said that during the spring, the task force would meet almost every day, but once the focus of the White House shifted to the economics of reopening the country, the frequency of official task force meetings has dropped to once a week.
Fauci said most of his interactions with the White House now are with Vice President Pence.
“We certainly interact with the vice president at the task force meetings, and the vice president makes our feelings known to the president, but direct involvement with the president and discussions, I have not done that in a while,” Fauci said.
Fauci said the country is in a “precarious” position, and people really need to understand how difficult the winter will be if coronavirus infections continue to spike the way they are now.
The United States on Thursday reported at least 75,049 new coronavirus cases, the second-highest daily total so far.
“We don’t want to shut the country down. Every time I talk about things that we need to do, people get concerned. We’re not talking about shutting down, but we’re talking about doubling down on some of the fundamental public health measures that we need to adhere to,” Fauci said, like the universal wearing of masks, physical distancing, avoiding large crowds and indoor dining.
“They seem rather simple, but they really do work,” he said.
The vaccine advisory committee, meeting remotely in an all-day session, will not review a specific vaccine because no company has applied for the FDA’s imprimatur. Rather, the group will provide views on the FDA’s standards governing whether a vaccine is sufficiently safe and effective to warrant an emergency use authorization. It will also weigh in on the conduct of clinical trials once a vaccine is cleared and monitoring safety on an ongoing basis.
Even a general discussion is an important milestone, especially after protracted political melodrama involving the vaccine review process, experts said.
“The visual of scientists sitting around the table carefully discussing what a safe and effective vaccine might look like is an important moment for the FDA,” said Jason L. Schwartz, assistant professor of health policy and management at the Yale School of Public Health. “For months, all the FDA could do was offer promises about how science would guide its decisions on the vaccine. This shows how that will happen as data begins to come in.”
The panel will offer the agency advice for navigating the “extraordinary and unprecedented steps” of clearing a vaccine on an emergency basis, said M. Miles Braun, former director of the FDA’s division of epidemiology and an adjunct professor at the Georgetown University School of Medicine, during a media briefing Wednesday. FDA officials will want to know they are “on firm ground, and not missing any issues,” Braun said.
The FDA has said it will hold additional advisory committee meetings to consider applications from vaccine makers, which could begin arriving as soon as mid-November.
The panel, called the Vaccines and Related Biological Products Advisory Committee, is made up mostly of academic experts in infectious diseases, immunology and biostatistics. Some members recused themselves because they work at hospitals where coronavirus vaccine trials are being conducted or are involved in the trials. They were replaced by temporary members, including Arnold Monto, a University of Michigan epidemiologist who will serve as committee chairman, according to documents on the FDA website.
The FDA on Wednesday posted the topics it wants to discuss with the committee, including the effects of vaccines in specific populations. One of the most complicated questions centers on how to continue clinical trials after a vaccine is authorized. Should participants who received the placebo be notified and allowed to get the vaccine? If so, will that hurt the trial’s ability to collect useful data on an ongoing basis, and how can that be mitigated?
The FDA has used advisory committees for decades to bulk up its expertise and win buy-in from the public and outside scientists on its decisions. The FDA is not required to take advice from the panels but often does. The vaccine committee is expected to play an especially important role given the political pressure exerted by the White House on the FDA in recent weeks and months.
The White House held up the guidance, but the FDA circumvented the blockade by publishing it as part of briefing materials provided
(Reuters) – The U.S. health regulator’s criteria for allowing emergency use of a COVID-19 vaccine and plans to monitor its safety after a regulatory go-ahead, are among the topics to be discussed at a closely watched meeting scheduled for Thursday.
Details posted on the Food and Drug Administration’s (FDA) website showed the U.S. Centers of Disease Control and Prevention has formulated plans to monitor safety and effectiveness of a vaccine even after the FDA allows for its emergency use.
The FDA panel would make recommendations at the end of the meeting, according to the agenda, but did not specify details.
The agenda also showed no specific application for a vaccine’s emergency use would be discussed at the meeting. The agency previously said it would hold multiple meetings in the future to discuss emergency use of a particular vaccine.
Pfizer Inc <PFE.N>, Moderna Inc <MRNA.O> and AstraZeneca <AZN.L> could provide early analyses of late-stage trials of their experimental vaccines this month or the next, following which regulators will consider regulatory authorization.
The companies did not immediately respond to a request for comment on whether they would be presenting at the meeting.
The FDA earlier this month told coronavirus vaccine developers it wants at least two months of safety data before authorizing emergency use, a requirement that likely pushes any U.S. vaccine availability past the Nov. 3 presidential election.
The meeting, which is open to the public for comments, is another example of steps health regulators are taking to assuage public distrust related to coronavirus vaccines, that are being developed at unprecedented speed.
There are no approved vaccines for the coronavirus, except two in Russia that are yet to finish Phase 3 clinical testing.
(Reporting by Manas Mishra in Bengaluru; Editing by Shounak Dasgupta)