Novo Nordisk's GLP-1 for Type II diabetes approved for first-line … – Endpoints News

Ry­bel­sus, No­vo Nordisk’s GLP-1 al­so known as semaglu­tide, snagged a la­bel up­date from the FDA, al­low­ing pa­tients to take it as a first-line treat­ment for Type II di­a­betes in 7 or 14 mg, the com­pa­ny an­nounced.
The up­date came af­ter its ini­tial ap­proval in 2019, when the drug hit the mar­ket as the first GLP-1 pill to en­ter the Type II di­a­betes mar­ket. And it re­mains the on­ly one. It’s an ana­log of the hor­mone glucagon-like pep­tide-1 (GLP-1).
Af­ter ap­proval, an­a­lysts pegged it as a block­buster drug with sales es­ti­mates rang­ing from $2 bil­lion to $5 bil­lion.
Un­til now, Ry­bel­sus could on­ly be used af­ter pa­tients had tried oth­er treat­ments.
No­vo Nordisk re­port­ed in 2021 that 80% of Ry­bel­sus pre­scrip­tions were to pa­tients who were new to GLP-1 cat­e­go­ry drugs.
“In the U.S., hun­dreds of thou­sands of peo­ple with type 2 di­a­betes have been pre­scribed this med­i­cine as part of their type 2 di­a­betes treat­ment reg­i­men to help low­er their A1C,” Doug Lan­ga, EVP of North Amer­i­ca op­er­a­tions and pres­i­dent of No­vo Nordisk, said in a state­ment.
A1C is a tech­ni­cal med­ical term re­fer­ring to the per­cent­age of sug­ar-coat­ed he­mo­glo­bin pro­teins in a per­son’s red blood cells.
Lan­ga added that the drug re­mains “a piv­otal part” of the com­pa­ny’s port­fo­lio.
Ry­bel­sus works by us­ing semaglu­tide and SNAC, an ab­sorp­tion en­hancer for semaglu­tide in the stom­ach, to in­crease in­sulin pro­duc­tion from the pan­creas while si­mul­ta­ne­ous­ly de­creas­ing sug­ar re­lease from the liv­er and slow­ing down food leav­ing the stom­ach.
Pfiz­er re­cent­ly joined the GLP-1 race with PF-07081532, a GLP-1 ag­o­nist. In De­cem­ber 2022, Pfiz­er be­gan Phase II tri­als in its part­ner­ship with So­sei Hep­tares to test the can­di­date on pa­tients with ei­ther Type II di­a­betes or obe­si­ty. In the tri­al, along with a place­bo or the can­di­date, some pa­tients with Type II di­a­betes will al­so be ran­dom­ized to No­vo Nordisk’s Ry­bel­sus.
Eli Lil­ly al­so has tirzepatide, mar­ket­ed as Moun­jaro, which won ap­proval in 2022 for adults with Type II di­a­betes. No­vo Nordisk has two oth­er semaglu­tide brands, Ozem­pic and We­govy. Ozem­pic was ap­proved in 2017 for pa­tients with Type II di­a­betes, while We­govy was ap­proved as a week­ly in­jec­tion for weight man­age­ment.
Transforming the US healthcare system will be complex, but an emerging class of tech-enabled providers are poised to support a breakthrough. Learn why the move to value-based care offers a potentially huge market opportunity, despite being in its early stages.
The unsustainable nature of US healthcare spending has long been a widely accepted fact, and expenditures touched 19.7% of GDP in 2020. The country now spends an estimated $12,318 per person on healthcare annually – far above Germany, the next biggest spender at $7,382 per head.
The FDA and the CDC are investigating a “preliminary signal” of whether there might be an increased risk of stroke for people who got Pfizer and BioNTech’s updated Covid-19 vaccine booster.
In a statement posted on the CDC’s website, the agency said its monitoring system for vaccine side effects had been triggered to look for a potential issue with the shots in people ages 65 and older.
A former senior staffer at Takeda was arrested this week over an alleged scheme to defraud the company of about $2.3 million.
Priya Bhambi, a former employee in Takeda’s technology operations group, has been charged with wire fraud along with Samuel Montronde. The defendants, who live together in Boston, were accused of scheming via text message and using the stolen funds to buy a Mercedes-Benz, according to an affidavit by FBI Special Agent Brendan Donlan.
AstraZeneca is retiring Lumoxiti, its third-line treatment for a rare type of blood cancer called hairy cell leukemia (HCL), the company confirmed to Endpoints News on Thursday.
The drug will be permanently discontinued in the US as of July 2023, in part due to competition from rivals, a spokesperson said in an email. The decision “does not reflect any new concerns about the safety or efficacy” of Lumoxiti, but rather “an evaluation of the utilization” of the drug and “the availability of other treatments that are more widely prescribed.”
Unlock this story instantly and join 156,100+ biopharma pros reading Endpoints daily — and it’s free.
The European Medicines Agency is working on new advice for healthcare providers treating patients with Zolgensma, five months after two child patient deaths in Russia and Kazakhstan.
That includes monitoring the liver function of patients treated with the gene therapy and quickly assessing cases of suspected liver damage, Reuters first reported.
The EMA released its own statement after the Pharmacovigilance Risk Assessment Committee meeting on Jan. 12:
Myovant and Pfizer are pointing up the fact that prostate cancer treatment Orgovyx is a pill in the first direct-to-consumer campaign for the brand.
The advertising pulls the middle syllable from the brand name, encouraging people to “GO with the facts” and talk to a doctor about the oral androgen deprivation therapy (ADT). Real patients and caregivers are featured on the brand website, which also includes a link to an Orgovyx resource called “The MANual.” That platform, launched last year, is meant to help patients when starting on the drug and includes a tracking app, educational material and prostate cancer support community connections.
Unlock this story instantly and join 156,100+ biopharma pros reading Endpoints daily — and it’s free.
The pharma industry knocked off the tech industry to take the No. 1-trusted industry spot in Ipsos’ just-released annual survey. More than one third (34%) of adults surveyed across 21 countries rated pharma companies as trustworthy, edging out the tech sector with a 33% average score.
While the rankings are relative, it’s still good news for pharma, which increased from 31% last year. Tech stayed even year-over-year, but it’s dropped from a high of 38% in 2018, the first year of the Ipsos Global Trustworthiness Monitor report. Other sectors that also increased for 2022 were government at 22%, up from 20% last year, and social media, also at 22% and up from 16% last year.
Unlock this story instantly and join 156,100+ biopharma pros reading Endpoints daily — and it’s free.
Arch Oncology ended its work on developing an anti-CD47 antibody and most employees have left the company, Endpoints News has learned.
The Brisbane, CA, and St. Louis biotech scrapped clinical development of the antibody, dubbed AO-176, according to an automatic reply email from a former clinical operations director.
All Arch employees were let go and the company “was in a wind-down situation,” according to the LinkedIn bio of Arch’s former VP of human resources.
Unlock this article along with other benefits by subscribing to one of our paid plans.
Researchers are already using gene editing to tackle rare inherited diseases. But in a new paper, researchers use that tool in mice to treat the leading cause of death in the world: heart disease.
In a study published in Science Thursday, Eric Olson, Simon Lebek and colleagues from UT Southwestern modified a gene in mice that encodes an enzyme that, when chronically overactive, can lead to an array of heart diseases. The enzyme, known as CaMKII𝛿, regulates heart function, and is one form of CaMKII, which plays important regulatory roles in many organs in the body.
Unlock this story instantly and join 156,100+ biopharma pros reading Endpoints daily — and it’s free.
Bioscience & Technology Business Center
The University of Kansas
Lawrence, Kansas<!–
2029 Becker Drive,
(785) 813-1733 –>
© Endpoints Company 2023
If you’re already an Endpoints subscriber, enter your email below for a magic link that lets you log in quickly without using a password. Please note the magic link is one-time use only and expires after 24 hours.
We’ll e-mail you a link to set a new password. Please note this link is one-time use only and is valid for only 24 hours.
ENDPOINTS NEWS Daily at 11:30 AM ET
EARLY EDITION Daily at 7:15 AM ET
ENDPOINTS PHARMA Daily at 2 PM ET
ENDPOINTS MARKETING RX Tue at 2 PM ET
ENDPOINTS FDA+ Wed at 2 PM ET
ENDPOINTS MANUFACTURING Thu at 2 PM ET
ENDPOINTS WEEKLY Sat at 6 AM ET

source