Kevin Kunzmann

The US Food and Drug Administration (FDA) has issued a letter to biopharmaceutical company Ardelyx, Inc, identifying deficiencies in the company’s New Drug Application (NDA) for investigative drug tenapanor, ahead of its PDUFA date next week.

The letter, received on July 13, stated the deficiencies of the NDA “preclude discussion” around the would-be labeling and post-marketing requirements for tenapanor as a drug for controlling serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis.

The FDA noted key issues in the NDA for tenapanor include size and clinical relevance of the treatment effect.

Though the letter stated the notification did not reflect a final decision on the NDA, a meeting requested by the company on the matters of the letter was denied by the FDA.

accompanying the news, Ardelyx president and chief executive officer Mike Raab expressed disappointment with the communication.

"This is an extremely disheartening and disappointing communication from the FDA, particularly following the weeks of label discussions that occurred in early April, the fact that our NDA submission included three pivotal trials across 1,000 patients, all which met their primary and key secondary endpoints, as well as the additional data analyses we submitted in late April in response to the FDA's requests," Raab said.

He stressed the company plans to work with FDA going forward to interpret the highlighted NDA deficiencies “and will seek to resolve them as quickly as possible.”

 50 mg, twice-daily oral tenapanor to increase bowel movements and decrease abdominal pain for patients with IBS-C.

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The issuance comes within a week of the planned PDUFA date for the drug's possible indication as an adult CKD therapy.

FDA Issues Letter to Ardelyx for Submission of Tenapanor for Chronic Kidney Disease

 Avicenna’s impact on precision medicine


 The state of lung cancer precision medicine


Lung cancer treatment is on the precipice of unheralded advancement in its field. The intersection of advanced diagnostics, targeted immunotherapy, and implementation of artificial intelligence-borne pathology has created a possibility of concise, individualized care.

Or, as many refer to it, precision medicine.

In this newest episode of Lungcast, American Lung Association (ALA) chief medical officer Al Rizzo, MD, sits down with Andrea Mazzocchi, PhD, co-founder and chief executive officer of Known Medicine, and adjunct professor at Wake Forest University.

After reviewing the ever-long beneficial teachings of Persian scientist Avicenna and his influence on modern precision medicine, Rizzo and Mazzocchi discuss the ins and outs of emerging lung cancer tools and capabilities.

Lungcast is a monthly respiratory health podcast series from the ALA, produced by 

Subscribe or listen to Lungcast on your favorite platforms:

https://open.spotify.com/show/1F3u1hKrwxi9snSQ0q3nti

https://podcasts.apple.com/us/podcast/lungcast/id1524712350

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The co-founder and CEO of Known Medicine dissects the art and science of how profiling biomarkers, epigenetics and the microenvironment may provide the synergy needed to revolutionize the oncologic landscape.

The Future of Lung Cancer Precision Medicine with Dr. Andrea Mazzocchi

Intensive lifestyle therapy provided in a workplace setting was associated with significant increases in muscle development and decreases in fasting blood glucose and HbA1c levels in patients with 

American Diabetes Association (ADA) 2021 Scientific Sessions

 this week, additionally showed that these outcomes were possible at the same time as reducing diabetes medication by approximately 60% in patients undergoing therapy.

Led by Mihoko Yoshino, MD, PhD, assistant professor of Medicine at the John T. Milliken Department of Medicine, Washington University School of Medicine in St. Louis, investigators conducted an 8-month randomized, controlled study observed intensive lifestyle therapy in patients with type 2 diabetes and obesity.

“Weight loss and exercise are the cornerstones of therapy for patients with obesity and type 2 diabetes,” they wrote. “However, successful compliance with therapy is difficult to achieve.”

Their assessment, conducted at a workplace setting, observed the benefit of intensive lifestyle therapy on patient bodyweight, cardiometabolic function, and cellular metabolic pathways.

Patients were assigned to either standard care (n = 8) or ITL (n = 10). Mean baseline patient BMI was 38±5 and 37±6, respectively. Fasting blood glucose levels were 161±19 mg/dl and 150±32 mg/dl, respectively. HbA1c levels were 7.6±1.1% and 7.0±1.1%, respectively.

Intensive lifestyle therapy included weekly diet-behavior therapy sessions for patients, as well as 4 weekly supervised resistance and endurance exercise training courses.

Yoshino and colleagues observed improvements in all cardiometabolic outcomes among patients treated with intensive lifestyle therapy versus standard care—insulin sensitivity,

β-cell function, and cardiorespiratory fitness (per VO2 peak during cycle ergometer exercise) each significant improved with the comprehensive therapy.

What’s more, intensive lifestyle therapy increased muscle NAD content by approximately 51% versus standard care (

 <.05). Investigators observed fasting blood glucose and HbA1c decreases of 108±31 mg/dl and 6.1±0.9%, respectively, among intensive lifestyle therapy patients. At the same time, diabetes medication use in this population decreased by 60%, versus no change in standard care patients.

Finally, weight loss per BMI was significantly greater in the intensive lifestyle therapy group at 8 weeks: 17±7% reduction versus 1±2% (

“We conclude that marked diet-induced weight loss and exercise training can be achieved in a structured worksite setting and has profound therapeutic cardiometabolic effects in people with obesity and type 2 diabetes,” investigators wrote.

The study, “Effect of Intense Lifestyle Therapy in People with Obesity and Type 2 Diabetes,” was presented at ADA 2021.

New findings show patients were able to more than halve type 2 diabetes medication while improving diabetic and cardiovascular parameters in 8 weeks.

Intensive Lifestyle Therapy Improves Glycemic Control, Lessens Diabetic Medication

Tirzepatide, a novel dual glucose-dependent insulinotropic polypeptide (GIP) and GLP-1 receptor agonist, showed superior and clinically meaningful improvement in metrics of glycemic control versus semaglutide in patients with 

 this week, additionally showed the investigative therapy bettered semaglutide—recently approved by the US Food and Drug Administration (FDA) for obese/overweight adult chronic weight management—in body weight reduction among treated patients.

The noninferiority SURPASS-2 trial of the Eli Lilly and Company product added to tirzepatide’s portfolio as a potential agent for type 2 diabetes management.

Led by Juan Pablo Frias, MD, Medical Director of the National Research Institute, investigators conducted the open-label, 40-week phase 3 assessment seeking noninferiority of once-weekly tirzepatide to semaglutide in patients with type 2 diabetes taking background metform.

They were randomized 1:1:1:1 to tirzepatide 5, 10 or 15 mg dose, or semaglutide 1 mg. Frias and colleagues sought a primary efficacy objective of tirzepatide 10 or 15 mg noninferiority versus semaglutide in mean HbA1C change from baseline to week 40.

Secondary endpoints included noninferiority of the lesser-dose tirzepatide (5 mg) for glycemic change per HbA1C, as well as superiority for all tirzepatide doses for HbA1C change, body weight and fasting serum glucose improvement, proportion of patients with HbA1C <7%, ≤6.5% and <5.7% at 40 weeks, and body weight loss of ≥5%, ≥10% and ≥15% at 40 weeks.

The 1879-patient population included a mean baseline HbA1C of 8.28%. Mean patient age was 56.6 years old, with a type 2 diabetes diagnosis duration of 8.6 years. Mean body mass index was 34.2 kg/m2.

Investigators observed superiority of tirzepatide versus semaglutide for mean change in HbA1C, fasting serum glucose, and body weight with all 3 doses at 40 weeks. Patients treated with tirzepatide also reported superiority in HbA1C and body weight loss targets at trial’s end.

Commonly reported adverse events in treated patients included gastrointestinal effects—mostly mild to moderate in severity. Instances of clinically significant or severe hypoglycemia events were low among treated patients.

“In conclusion, all tirzepatide doses demonstrated superior and clinically meaningful improvement in glycemic control and substantial weight loss vs. semaglutide 1 mg in people with type 2 diabetes treated with metformin,” investigators wrote.

Efficacy and Safety of Tirzepatide vs. Semaglutide Once-Weekly as Add-On Therapy to Metformin in People with Type 2 Diabetes (SURPASS-2)

New SUPRASS-2 findings show the dual GIP/GLP-1 agonist provided superior type 2 diabetes management outcomes at 3 different doses.