The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding the New Drug Application for investigational Zynquista (sotagliflozin)*, a dual SGLT1 and SGLT2 inhibitor for the treatment of adults with type 1 diabetes in combination with insulin.
About Lexicon Pharmaceutical.
*Sotagliflozin is an investigational drug and is under regulatory review by the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA). The EMA and FDA have conditionally accepted Zynquista™ as the trade name for sotagliflozin.
About Sanofi
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Sanofi Forward-Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi's ability to benefit from external growth opportunities and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic conditions, the impact of cost containment initiatives and subsequent changes thereto, the average number of shares outstanding as well as those discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2018. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.
Lexicon Forward-Looking Statements
This press release contains “forward-looking statements,” including statements relating to Lexicon’s and Sanofi’s clinical development of and regulatory filings for Zynquista (sotagliflozin) and the potential therapeutic and commercial potential of Zynquista. In addition, this press release also contains forward-looking statements relating to Lexicon’s growth and future operating results, discovery, development and commercialization of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management’s current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including the risk that the FDA and other regulatory authorities may not grant regulatory approval of Zynquista in accordance with Lexicon’s currently anticipated timelines or at all, and the risk that such regulatory approvals, if granted, may have significant limitations on the approved use of Zynquista. As a result, Zynquista may never be successfully commercialized. Other risks include Lexicon’s ability to meet its capital requirements, successfully commercialize XERMELO (telotristat ethyl), successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of LX2761, LX9211 and its other potential drug candidates on its anticipated timelines, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its drug candidates. Any of these risks, uncertainties and other factors may cause Lexicon’s actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under “Risk Factors” in Lexicon’s annual report on Form 10-K for the year ended December 31, 2018, as filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.
Source: Sanofi
As society relaxes its rules around marijuana, U.S. teens seem to be responding by using the drug in much bigger numbers than a generation ago, new research shows.
ReplyDeleteThe study looked at 1991-2017 U.S. federal health data on more than 200,000 high school students. It found that the number who said they'd used pot at least once over the past month rose 10-fold -- from 0.6% in 1991 to 6.3% by 2017.
Many are becoming "dual users" of both marijuana and alcohol: The number of teens who admit to using both substances at least once a month has almost doubled -- from 3.6% in 1991 to 7.6% in 2017.
Why these big changes? Study author Hongying Dai believes changing social mores and legislation has been a big factor.
"Public opinion on marijuana use have changed dramatically, and restrictions on marijuana use have been relaxing," wrote Dai, of the University of Nebraska's College of Public Health in Omaha. "Currently, 33 states and the District of Columbia have laws in place that allow marijuana to be used medically, recreationally, or both."
There was some good news from the study -- teens are increasingly turning away from cancer-causing cigarettes and other combustible tobacco. According to the study, teen smoking has dropped from 4.4% of high school students in 1991 to just 1.3% today. Teens are drinking much less, too, with alcohol use falling from about 24% of teens in 1991 to 12.5% in 2017.
Still, the "surge" in marijuana use is troubling, Dai said, and "highlights the importance of marijuana prevention among youths."
She added that usage rates increased most dramatically among black and Hispanic youth. Over the time period covered by the study, use of marijuana by black teens soared from 2% to 13.5%, and from less than 1% to nearly 9% among Hispanics. In comparison, in 1991 0.3% of white teens said they'd used pot over the past month, and 3.7% said so by 2017.
Dr. Scott Krakower helps direct psychiatry, including addiction issues, at Zucker Hillside Hospital in Glen Oaks, N.Y. He wasn't surprised by the marijuana findings, saying that "with diminishing perceptions that it is harmful," of course, youth are turning more readily to the drug.
That notion was backed up by the study: According to the data, "the percentage of high school seniors who perceived regular use of marijuana as harmful dropped from 78.6% in 1991 to 29% in 2017," Dai wrote.
But another expert believes that all that extra pot use is definitely not harmless.
"The adolescent brain, particularly the prefrontal cortex areas that control judgment and decision-making, is not fully developed until the early 20s, which raises questions about how any substance use may affect the developing teenage brain," said Dr. David Fagan. He helps direct pediatrics at Cohen Children's Medical Center in New Hyde Park, N.Y.
Fagan said that there are "multiple longitudinal studies that link marijuana use with higher rates of mental health disorders, such as depression and psychosis, raising concerns about longer-term psychiatric effects."
He also believes the study has left out one major destructive trend: the rise of the e-cigarette.
Yes, smoked tobacco has become largely unpopular among teens, but vaping has more than taken its place, Fagan said.
"For the latest data as of 2018, the National Youth Tobacco Survey reported 20.8% of high school students and 4.9% of middle school students currently used e-cigarettes [defined as use of an e-cigarette at least one day in the past 30 days]," he noted.
"E-cigarettes -- Juuls, etc. -- are the most common tobacco product used by teenagers today, and the numbers are skyrocketing," Fagan said.
Nicole and Jonathan Hughes, a teacher and a physician with three young children, were acutely aware of the dangers of swimming pools and lakes. From fenced-off pools to life jackets to constant supervision, they did everything right.
ReplyDeleteTragedy struck anyway.
Last June, as the family was about to head to an Alabama beach for an evening crab hunt, 3-year-old Levi somehow slipped out of their vacation house and found his way to the pool. In what seemed like an instant he was face down in the water, and couldn't be revived.
"We weren't neglectful, but somehow we failed to keep him safe," Nicole said. "Everybody knows about statistics, but the reality is nobody thinks it's going to happen to them."
Nicole, who lives in Bristol, Tennessee, has channeled her grief into activism, speaking out about a leading cause of preventable death among children: drowning.
"There's such a stigma that it's even hard to say the word," she said. "People say it's about 'water safety.' No, it's about drowning. We have to stop tiptoeing around it."
According to the Centers for Disease Control and Prevention, drowning is the No. 1 cause of unintentional death between ages 1 and 4, and the No. 2 cause between ages 5 and 9. The latest national data show 702 U.S. children under age 15 drowned in 2017.
The figures are not broken down by ethnic group, but minorities may be at even greater risk. The USA Swimming Foundation reports 64 percent of African American children and 45 percent of Hispanic children have low or no swimming ability, compared to 40 percent of white children.
The American Academy of Pediatrics recently updated its recommendations for preventing drowning in children, ranging from vigilance at bath time and emptying buckets and wading pools immediately after use to teaching children to swim and encouraging teenagers to learn CPR.
"We've got to do a better job," said Dr. Sarah Denny, lead author of the new guidelines. "Drownings continue to happen. Parents must be aware of the risks and take action to prevent drowning."
Denny, a pediatrician at Nationwide Children's Hospital in Columbus, Ohio, is particularly concerned about young children.
"Toddlers are curious, they're newly mobile, they're exploring their environment and they have no concept of the risk of water," she said.
She stressed that "layers of protection" are key to avoiding tragedy. Those layers include secure fences around pools, close supervision when children are around water, risk assessment and planning for children at every age level, and education, from the pediatrician's office to public service announcements.
One current announcement features Olympic gold medal skier Bode Miller and his wife Morgan, whose 19-month-old daughter Emmy drowned in a pool in California ; on the same day that Levi Hughes died in Alabama.
"You have to be vigilant, as if it's a lion waiting to snatch your child," Morgan says in the video message.
Nicole Hughes wants to encourage that vigilance with a "Water Guardian" tag, complete with lanyard, that adults can hand off to one another to emphasize the responsibility of supervising children in the water. They're available from her new foundation Levi's Legacy.
"It's another layer of protection," she said. "But the most important goal is just awareness."
DeleteIf a drowning emergency should occur, "every second makes a difference," said Dr. Vinay Nadkarni, a critical care expert at The Children's Hospital of Philadelphia.
His recommendations start with calling 911 immediately. Get the victim to a safe area "and assess for signs of life. If they're not breathing normally, start CPR."
For drowning victims, the American Heart Association recommends CPR with chest compressions and rescue breaths.
"Prevention is the best cure," but a devastating accident can still happen, Nadkarni said, which makes knowing CPR no less important than a good fence.
"If you do not know CPR," Nadkarni said, "you should not have a pool."