Regulatory tracker: Bayer adds new cardiovascular outcomes nod to Kerendia

Fierce Pharma is tracking regulatory rumblings as they happen. Check out our new tracker for the latest on FDA moves, application hits and misses, approvals and more. Keep reading for regular updates.

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UPDATED: Friday, Sept. 2 at 9:48 a.m. ET

Bayer has added more cardiovascular outcomes data to Kerendia's U.S. label. The prescribing information includes data from the FIGARO-DKD trial, in which the majority of patients had earlier-stage chronic kidney disease associated with Type 2 diabetes. Bayer said the trial was the first of its kind CV outcomes trial in this population. 

In FIGARO-DKD, Kerendia cut the incidence of CV deaths, nonfatal heart attack and stroke or hospitalization for heart failure on a composite endpoint by 13% over placebo. The treatment effect was mainly driven by an effect on hospitalization for heart failure, though CV death also contributed to the treatment effect, the label shows.

Before the new addition, Kerendia's FIDELIO-DKD trial already showed a 14% reduction on the same composite CV outcomes endpoint in a slightly different kidney disease population.

UPDATED: Monday, Aug. 29 at 9:35 a.m. ET

Ten months after a quick FDA nod, Novartis' next-generation leukemia drug Scemblix has won a European Commission approval for Philadelphia chromosome-positive chronic myeloid leukemia (CML) after two or more prior tyrosine kinase inhibitors. 

Scemblix got its accelerated approval in the U.S. in October 2021 after showing it nearly doubled a major molecular response rate versus Pfizer’s Bosulif at 25.5% versus 13.2%, respectively, after 24 weeks. Longer 96-week follow-up data showed a 37.6% major molecular response rate for Scemblix, compared with 15.8% by Bosulif. The Novartis drug is also linked to a markedly lower side effect-related discontinuation rate. Novartis also plans to use the updated results to turn Scemblix's accelerated approval into a full nod.

Novartis pushed Scemblix to the market as its older blockbuster CML med Tasigna is slated to lose U.S. exclusivity in 2023.

Teva has snagged a European Commission authorization for a biosimilar referencing Roche and Novartis' Lucentis. Called Ranivisio, the drug will be the first ophthalmology biosimilar of Lucentis to be marketed in EU, Teva said, and it's approved in all five Lucentis indications in adults, including age-related macular degeneration.

Before the EU go-ahead, Teva already launched the drug under the brand name Ongavia in the U.K. in July. Teva got rights to the Lucentis biosim in Europe, Canada, Israel and New Zealand last year from Bioeq

In the U.S., the drug is owned by Coherus BioSciences. Earlier this week, the drug, to be sold as Cimerli, became the first interchangeable Lucentis biosimilar approved by the FDA.

Meanwhile, Biogen and Samsung Bioepis have already commenced U.S. marketing activities of their Lucentis biosim, known as Byooviz.

UPDATED: Wednesday, Aug. 25 at 9:35 a.m. ET

European regulators have accepted the application for CSL Vifor and Travere Therapeutics’ sparsentan in the rare kidney disorder IgA nephropathy (IgAN), teeing up a potential approval in the second half of 2023. If the med passes muster with regulators, sparsentan would clinch conditional marketing approval (CMA) in all European Union member states, plus Iceland, Lichtenstein and Norway, CSL and Travere said in a release.

The partners have girded their filing with topline interim data from the late-stage Protect study evaluating sparsentan in IgAN, which CSL and Travere note is the leading cause of end-stage kidney disease (ESKD).

At the trial's 36-week mark, patients on sparsentan hit a 49.8% mean reduction in proteinuria—or high levels of protein in the urine—from baseline. That compared with a 15.1% mean reduction from baseline in patients on the control drug irbesartan. Sparsentan was generally well-tolerated and had a safety profile on par with irbesartan, according to preliminary results from the study’s midpoint analysis.

CSL and Travere are also pitting sparsentan against focal segmental glomerulosclerosis (FSGS) in the phase 3 Duplex study. Sparsentan has snagged a priority review from the U.S. FDA in IgA nephropathy and boasts orphan drug designation for IgAN and FSGS in Europe and the U.S.

Elsewhere on the kidney disease front, Merck & Co. has snagged fast-track designation on its midphase asset MK-2060, which the company is developing as a potential standard-of-care anticoagulation therapy for end-stage renal disease (ESRD).

As a dual factor XI/XAa inhibitor, MK-2060 could triumph where anticoagulants such as factor Xa inhibitors have fallen short by preventing blood clots in patients with higher bleeding risks.

The fast track tag, meanwhile, covers the use of MK-2060 to reduce major thrombotic cardiovascular events in ESRD patients.

Merck’s ESRD contender is one of eight new approval’s the company’s cardiovascular team is targeting through to 2030. If the company meets its R&D goals, it thinks the franchise could pull down more than $10 billion in peak revenue by around 2035. That could in turn soften the blow as Merck starts to contend with Keytruda’s exclusivity loss. Fierce Biotech

Novartis snagged a thumbs up for its radioligand drug Pluvicto in the United Kingdom, plus a nod for companion diagnostic Locametz, to treat adults with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC). Specifically, the drug has been cleared in patients who’ve received androgen receptor inhibitors and taxane-based chemotherapy, or for those who aren’t a good fit for taxanes.

The U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) issued its marketing nod on alternate primary endpoint results from the phase 3 vision trial, which evaluated Pluvicto in patients with progressive PSMA positive mCRPC who’d been treated with at least on AR inhibitor and one or two taxane regimens.

In the study, Pluvicto plus standard of care help patients liver longer and was more effective at thwarting disease progression than standard care alone, Novartis said. Patients on the Swiss pharma’s radioligand therapy reported a higher rate of side effects than those on standard care. The most common side effects were fatigue, dry mouth, nausea, anemia, decreased appetite and constipation.

Minerva Neurosciences’ schizophrenia drug application is off to the FDA, the company said early this week. The company’s candidate roluperidone is angling for an approval to treat the negative symptoms of schizophrenia, which the company suggests is a “significant unmet medical need.”

In Schizophrenia, “positive” refers to symptoms that are actively present, such as auditory and visual hallucinations, delusions, disorganized speech and more. “Negative,” meanwhile, refers to an absence or lack of normal mental functioning involving thinking, behavior and perception, according to WebMD. This can include symptoms like lack of pleasure, which is known as anhedonia.

There are currently no approved therapies in the U.S. for the negative symptoms of the disease, Remy Luthringer, executive chairman and chief executive officer of Minerva, said in a statement.

“While positive symptoms of schizophrenia are generally well managed with antipsychotics, negative symptoms are often the main burden of illness and can impact the patients’ quality of life as a result of disabilities caused by impaired vocational and social skills,” the CEO added.

UPDATED: Tuesday, Aug. 16 at 8:45 a.m. ET

The FDA has received Roche’s filing for Polivy and Rituxan, plus cyclophosphamide, doxorubicin and prednisone, in patients with previously untreated diffuse large B-cell lymphoma (DLBCL). With Roche’s application in hand, the FDA has set up a regulatory action date of April 2, 2023.

Analysts at Jefferies have previously estimated Polivy’s frontline label expansion could mean $2.1 billion in peak sales for the drug, which was first approved in 2019.

Roche’s Polivy application leverages data from the late-stage Polarix trial, which showed the drug combo helped slash the risk of disease progression, relapse or death by 27% versus standard of care at a median follow up of 28.2 months. The Polivy combo’s safety was on par with profiles seen in previous clinical trials, Roche said.

That study earned the Polivy combo regimen a European approval in May. Meanwhile, back in April, Roche’s pharma chief Bill Anderson told investors the FDA had asked for additional data on Polarix before Roche could file with the U.S. regulator.

Merck and AstraZeneca’s Lynparza is poised for a speedy trip through the FDA after the regulator blessed a combination of the drug with abiraterone and prednisone or prednisolone alone with a priority review in adults with metastatic castration-resistant prostate cancer (mCRPC).

The decision sets up an FDA decision date in the fourth quarter of 2022, AstraZeneca said in a release.

AZ and Merck’s application hinges on data from the phase 3 PROpel study, which showed the Lynparza combo cut the risk of disease progression or death by 34% versus abiraterone alone. Median progression-free survival for patients on the Lynparza regimen was 24.8 months, compared to 16.6 for patients on the control drug.

Lynparza’s suffered some turbulence in recent months. Look no further than the LYNK-003 study testing Lynparza alone and alongside Avastin as a first-line maintenance treatment for colorectal cancer that has not progressed after first-line induction. At an interim analysis in that trial, an independent data monitoring panel found neither regimens could improve upon Avastin’s combination with chemotherapy in terms of stalling tumor progression or death.