Lilly gets FDA review for empagliflozin in chronic kidney disease

The FDA has accepted a supplemental New Drug Application (sNDA) for Jardiance (empagliflozin) tablets as a potential therapy to reduce the risk of kidney disease progression and cardiovascular death in adults with chronic kidney disease (CKD).

Some 37 million people in the U.S. have CKD.

Lilly (NYSE:LLY) is developing the drug with Boehringer Ingelheim.

The supplemental New Drug Application includes data from the landmark EMPA-KIDNEY Phase 3 study, which found that empagliflozin led to a significant reduction in the risk of kidney disease progression or cardiovascular death in adults with CKD. In the study, the drug on top of  standard of care reduced the risk of kidney disease progression or cardiovascular death in adults by 28% compared with placebo.

EMPA-KIDNEY is an abbreviation of Empagliflozin in the Management of Patients with Advanced Chronic Kidney Disease.

The randomized, double-blind, placebo-controlled study (NCT03594110) enroll…

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Why the immunotherapy startup 3T Biosciences is working with Boehringer Ingelheim

At the dawn of 2023, 3T Biosciences and Boehringer Ingelheim (BI) revealed a strategic collaboration and licensing agreement focused on the discovery and development of next-generation cancer therapies focused on high unmet patient needs.

The alliance unites 3T Biosciences’ 3T-TRACE (T-Cell Receptor Antigen and Cross-Reactivity Engine) discovery platform and Boehringer Ingelheim‘s focus on cancer cell-directed and immune cell-targeting compounds.

“It’s a collaboration based on the strengths of both companies,” said Stefan Scherer, 3T Biosciences CEO, in an interview at the J.P. Morgan Healthcare Conference.

The TRACE discovery platform

In the alliance, Boehringer Ingelheim will contribute patient-derived TCR data to help 3T with target discovery, identifying antigens with its 3T TRACE discovery platform.

Stefan Scherer

The TRACE platform draws from diverse t…

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Why the immunotherapy startup 3T Biosciences is working with Boehringer Ingelheim

At the dawn of 2023, 3T Biosciences and Boehringer Ingelheim (BI) revealed a strategic collaboration and licensing agreement focused on the discovery and development of next-generation cancer therapies focused on high unmet patient needs.

The alliance unites 3T Biosciences’ 3T-TRACE (T-Cell Receptor Antigen and Cross-Reactivity Engine) discovery platform and Boehringer Ingelheim‘s focus on cancer cell-directed and immune cell-targeting compounds.

“It’s a collaboration based on the strengths of both companies,” said Stefan Scherer, 3T Biosciences CEO, in an interview at the J.P. Morgan Healthcare Conference.

The TRACE discovery platform

In the alliance, Boehringer Ingelheim will contribute patient-derived TCR data to help 3T with target discovery, identifying antigens with its 3T TRACE discovery platform.

Stefan Scherer

The TRACE platform draws from diverse t…

Read more
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Boehringer Ingelheim launches Phase 3 study for novel IPF therapy

Currently, there are only two FDA-approved drugs for idiopathic pulmonary fibrosis (IPF) — Ofev (nintedanib) from Boehringer Ingelheim and Esbriet (pirfenidone) from Genentech.

Now, Boehringer Ingelheim is announcing the launch of the global FIBRONEER-IPF study focused on BI 1015550, an experimental phosphodiesterase 4B (PDE4B) inhibitor, in idiopathic pulmonary fibrosis (IPF).

The study is part of a broader FIBRONEER program that includes FIBRONEER-ILD for progressive fibrosing interstitial lung diseases.

FDA has granted Orphan Drug Designation to BI 1015550 in IPF.

The prognosis for patients diagnosed with IPF tends to be poor.

Boehringer Ingelheim discovered that the BI 1015550 had anti-fibrotic effects in preclinical and lung fibrosis cellular models.

In the 1990s, Schering helped forge a path for BI 1015550 by developing a selective phosphodiesterase-4 inhibitor known as Rolipram as a possible antidepressant.

Boehringer I…

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Lilly stops Phase 3 Jardiance trial early thanks to clear positive efficacy data

The independent data monitoring committee overseeing the Phase 3 EMPA-KIDNEY trial investigating Lilly’s (NYSE:LLY) Jardiance (empagliflozin) concluded the therapy showed positive efficacy in a formal interim assessment.

Boehringer Ingelheim co-developed empagliflozin with Lilly.

The EMPA-KIDNEY trial focused on treating adults with chronic kidney disease (CKD).

The committee recommended that the Phase 3 study be stopped early, given clearly positive data.

Earlier, the Medical Research Council (MRC) Population Health Research Unit at the University of Oxford, Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY), concluded Jardiance met the prespecified positive efficacy criteria.

Jardiance was first FDA approved as a treatment for type 2 diabetes in 2014. An indication followed for reducing the risk of cardiovascular death in adults with type 2 diabetes in 2016.

Approvals followed in 2021 and 2022 for heart failure with r…

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FDA lengths review of Skyrizi for Crohn’s

AbbVie (NYSE:ABBV) has announced that the FDA will prolong the review period for Skyrizi (risankizumab-rzaa) to treat moderate to severe Crohn’s disease in patients 16 years and older.

The agency decided to extend the Prescription Drug User Fee Act (PDUFA) action date for the indication by three months to review additional data submitted from the sponsor related in part to an on-body injector.

FDA first approved Skyrizi, an interleukin-23 subunit p19 inhibitor, for moderate to severe plaque psoriasis in adults. Then, in January, it won an indication for adults with active psoriatic arthritis.

AbbVie developed the drug in partnership with Boehringer Ingelheim.

Last year, sales of the drug were $2.939 billion internationally.

AbbVie has also filed an application with the European Medicines Agency asking for approval of Skyrizi to treat patients at least 16 years with moderate to severe Crohn’s disease.

ABBV shares ticked do…

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FDA approves Lilly’s Jardiance for heart failure 

Eli Lilly and Company (NYSE:LLY) has announced that the FDA has approved Jardiance (empagliflozin) 10 mg to lower the risk of cardiovascular death and hospitalization in adults with heart failure.

Lilly developed the drug, an SGLT2 inhibitor, in collaboration with Boehringer Ingelheim.

Jardiance is contraindicated in adults with type 1 diabetes, given its potential to elevate the risk of ketoacidosis in such patients.

It is also contraindicated in patients who are hypersensitive to empagliflozin or the excipients in Jardiance.

FDA first approved Jardiance as a treatment for type 2 diabetes in 2014.

In 2016, it won an indication for reducing the risk of cardiovascular death in adults with type 2 diabetes.

Lilly also notes that the drug is not recommended for improving glycemic control in adults with type 2 diabetes with an estimated glomerular filtration rate (eGFR) under 30 mL/min/1.73 m2.

The company notes that the treatment …

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J&J and Roche named to Clarivate’s Top 100 Global Innovators list 

Photo by Chokniti Khongchum from Pexels

Few healthcare companies were included in the annual ranking of innovative companies from the analytics firm Clarivate plc (NYSE:CLVT).

Two companies in pharma and another in medtech, however, made the cut.

Johnson & Johnson was featured for the second consecutive year as a top 100 Global innovator.

Roche was included for the 11th consecutive year in the report.

In medtech, Philips was included for the second consecutive year.

Clarivate notes the fragmented nature of pharmaceutical research contributes to the limited number of companies in the ranking. Given the elevated role of academia and contract firms in drug discovery and development, it is more challenging for any single entity to stand out in the industry.

Additionally, Clarivate concluded that the ability of the pharmaceutical sector to innovate has fallen since last year…

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FDA approves first interchangeable Humira biosimilar to Humira

Last year, Humira (adalimumab) was the top-selling drug in the U.S., racking up nearly $20 billion in international sales.

Now, Boehringer Ingelheim’s Cyltezo (adalimumab-adbm) has become the first interchangeable Humira biosimilar.

First winning FDA approval in August 2017, Cyltezo is a tumor necrosis factor blocker indicated for everything from arthritis to Crohn’s, ulcerative colitis and plaque psoriasis.

The FDA decided to grant interchangeable status to Cyltezo based on Phase 3 randomized VOLTAIRE-X clinical trial.

FDA allows interchangeable biosimilars to be substituted for the reference product without the prescriber modifying the prescription.

“We are proud to be the company driving the advancement of biosimilars and delivering the first and only Interchangeable biosimilar with Humira,” said Thomas Seck, senior vice president, medicine and regulatory affairs at Boehringer Ingelheim, in a statement. “The Interchangeability status of …

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Boehringer Ingelheim acquires Abexxa Biologics and its targeted cancer therapies

Boehringer Ingelheim announced today that it acquired Abexxa Biologics, a developer of precision medicines for treating cancer.

Acquiring Abexxa, which utilizes a new approach in immuno-oncology and oncology research, offers Boehringer Ingelheim access to the company’s expertise in targeting cancer-specific proteins located inside the cell instead of those expressed on the cell membrane, according to a news release.

The proteins targeted by Abexxa’s technology enlarges the pool of potential cancer antigen targets, which could lead to the development of cancer immunotherapies that are effective in a broader range of patients and cancer types, the company said.

“The acquisition of Abexxa bolsters our commitment to tumor-antigen discovery and new ways of targeting intracellular antigens. Their cutting-edge know-how and technologies for antigen discovery and novel antibody generation strongly complement the current approaches we have been applyin…

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Boehringer Ingelheim teams up with GoodRx on cost-savings initiative  

Boehringer Ingelheim (Ingelheim, Germany) has teamed up with the prescription drug pricing tracker GoodRx (NSDQ:GDRX) to facilitate patients’ access to cost savings. For instance, people with type 2 diabetes or chronic obstructive pulmonary disease (COPD) can use GoodRx to enroll in copay programs for relevant Boehringer Ingelheim drugs.

The two companies estimate that the alliance will provide patients access to roughly $15 million in annual savings.

Diabetes and COPD are among the most common chronic diseases in the U.S. The former affects approximately one in 10 Americans while more than 16 million people in the U.S. have COPD, according to the CDC.

Drugs covered in the program include the following:

Jardiance (empagliflozin). Synjardy (empagliflozin/metformin HCI). Synjardy XR (empagliflozin/metformin HCI extended-release). Spiriva Respimat (tiotropium bromide). Stiolto Respimat (tiotropium bromide and olodaterol). Combivent Respimat (ipratropiu…
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Nanoform and Boehringer Ingelheim execute master services agreement

Nanoparticle medicine specialist Nanoform (Helsinki, Finland) and Boehringer Ingelheim (Ingelheim am Rhein, Germany) will collaborate on proof-of-concept studies related to Nanoform’s CESS technology.

The master services agreement enables the two parties to move forward with pre-clinical research related to CESS, an acronym for “Controlled Expansion of Supercritical Solutions.”

CESS has the potential to optimize the bioavailability and solubility of new drug candidates, according to Nanoform, which are central drivers of drug development failures.

“This is the first step toward what we hope will be a long and fruitful partnership between our companies,” said Christian Jones, CCO of Nanoform, in a statement.

Earlier this year, Nanoform struck a deal with Celanese Corp. (NYSE:CE), a specialty materials company. The two companies intend to collaborate on nanoparticle-enabled drug delivery to use Celanese’s copolymer delivery technology for drug-eluti…

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