Court dismisses Astra’s lawsuit over IRA price talks; Ozempic shows benefits to kidney, heart in diabetics with CKD

By PharmaCompass

2024-03-07

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This week’s Phispers brings updates on the Inflation Regulation Act (IRA) in the US. A federal district court judge rejected AstraZeneca’s claims that the drug price negotiations under IRA violate the Fifth Amendment of the US Constitution. The negotiation program currently foresees adding 10 to 20 drugs a year through 2029, and Biden plans to increase this to 50.

Novo Nordisk’s diabetes med Ozempic reduced the risk of kidney disease progression and death from cardiovascular or kidney complications by 24 percent in diabetic patients with chronic kidney disease (CKD). Additionally, in the first clinical trial of Ozempic in people with HIV and a type of liver condition, participants (on average) experienced a 31 percent reduction in liver fat.

The World Bank, UN and the Gates Foundation have come together and pledged nearly US$ 600 million to eradicate cervical cancer. Cancer-causing benzene has now been found in acne products. And, the WHO has warned of growing resistance to GSK’s HIV drug — dolutegravir.

Judge rejects Astra’s lawsuit calling Medicare price talks unconstitutional

A federal judge has rejected AstraZeneca’s claims that the Inflation Reduction Act’s (IRA) drug price negotiations are unconstitutional. The Anglo-Swedish drugmaker’s blockbuster drug Farxiga (dapagliflozin) for CKD, type 2 diabetes, and heart failure was among the 10 treatments chosen for price negotiations.

The US Medicare health insurance program covers 66 million Americans mostly over 65 years. Last August, the Biden government had allowed Medicare to negotiate the prices of 10 drugs with their manufacturers, via the IRA. The list included drugs like Stelara, Farxiga, Imbruvica, Eliquis, and Entresto. Astra had contended that this violated the Fifth Amendment of the US Constitution, which states private property shall not “be taken for public use, without just compensation.”

Drugmakers respond with counter offers: All the manufacturers of the 10 drugs have responded with counter offers after the United States Department of Health and Human Service (HHS) sent them initial offers on February 1. With negotiations now underway, the HHS was “glad the drug companies are coming to the table.”

‘Medicare should negotiate for at least 50 drugs’: The US President Joe Biden will call on Congress to expand the number of drugs subject to annual Medicare price negotiations. The program currently foresees adding 10 to 20 drugs a year through 2029, and Biden will propose increasing this to at least 50, a White House press statement said.

Ozempic cuts risk of CKD progression, cardiac death in late-stage trial

Novo Nordisk’s broadly used blockbuster diabetes drug Ozempic (semaglutide) slashed the risk of kidney disease progression and death from cardiovascular or kidney complications by 24 percent in diabetic patients with CKD. About 40 percent of people with type 2 diabetes have CKD. Confident about the efficacy, the drugmaker has decided to stop the trial a year ahead of schedule. Novo will file for expanded approvals for Ozempic in the US and EU this year.

Reduces severity of liver disease in people with HIV: Ozempic also showed benefits in HIV. The drug was found to be safe and it reduced the amount of fat in the liver by 31 percent in people with HIV and a liver disease, known as metabolic dysfunction-associated steatotic liver disease (MASLD). In the first clinical trial of semaglutide in people with HIV for MASLD, participants experienced a 31 percent reduction in liver fat on average, with 29 percent of participants experiencing a complete resolution of MASLD (i.e. their liver fat decreased to 5 percent or less).

Akero’s drug shows promising long-term benefits for MASH patients

Akero Therapeutics’ experimental drug efruxifermin significantly reduced scarring after 96 weeks while treating patients with metabolic dysfunction-associated steatohepatitis (MASH), a liver disease. MASH causes histologic liver damage and occurs in patients who are not alcoholics and are often obese or have type 2 diabetes. In fact, the condition is the next target of obesity drugs. In the mid-stage study, biopsies showed 75 percent of the patients experienced a reduction in liver scarring by at least one stage on the higher dose and 46 percent did so on the lower dose. The condition has no approved drugs in the US and affects over 17 million people in the country.

Cancer-causing benzene now found in acne products like Clearasil, Proactiv

High levels of benzene, a known carcinogen, have now been found in topical acne treatments, Valisure said. The Connecticut-based company has issued a citizen petition calling on the FDA to “recall and suspend sales of benzoyl peroxide from the US market.” Unacceptably high levels of benzene were found in acne products including popular household brands like Clearasil, Proactiv, and PanOxyl, as well as products from Estée Lauder, Walmart, Target, Walgreens, and Clinique. According to Valisure, this was because benzoyl peroxide decomposed into benzene over time when used with substances in acne medication.

WHO warns of growing resistance to GSK’s HIV drug — dolutegravir

The World Health Organization (WHO) had recommended GSK’s Tivicay (dolutegravir) back in 2018 as a preferred treatment for the virus. But now, the organization has cited surveys from four countries to suggest that resistance to the GSK drug has exceeded levels observed in clinical trials.

Meanwhile, GSK has said a new investigational formulation of cabotegravir, known as cabotegravir ultra long-acting (CAB-ULA), can be administered at intervals of at least four months, based on results from a phase 1 trial. The current version of the HIV prevention and treatment drug (cabotegravir) requires dosing every two months. The British drugmaker’s HIV-focused unit, ViiV Healthcare, plans to conduct large-scale trials later in 2024.

World Bank, Gates Foundation, UN pledge US US$ 600 mn to end cervical cancer

At the first-ever meet of the Global Cervical Cancer Elimination Forum in Colombia, global health donors have pledged nearly US$ 600 million to rid the world of cervical cancer. Those donors included the World Bank (US$ 400 million), the Bill & Melinda Gates Foundation (US$ 180 million), and the UN children's agency UNICEF (US$ 10 million).

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