Eli Lilly, Boehringer Ingelheim’s Jardiance Giving Competition to AstraZeneca’s Farxiga with EU Approval

Jardiance, the diabetes blockbuster from Eli Lilly and Boehringer Ingelheim, recently received a Heart Failure label expansion in the United States. Now, the drug is expanding into Europe, with a nod that might help it catch up to it’s rival i.e. AstraZeneca’s SGLT2 Farxiga.

The EU made its decision based on the findings of Jardiance’s late-stage EMPEROR-Preserved study, which revealed that the medicine reduced the risk of cardiovascular death or heart failure hospitalization by 21%. According to Boehringer, the drug’s benefit was found regardless of the patients’ ejection fraction or diabetes status.

Jardiance’s label expansion should give it an advantage over AstraZeneca’s entrenched SGLT2 competitor Farxiga, known as Forxiga in Europe, which beat Jardiance to the cardiovascular punch back in 2020. Farxiga became the first drug in its class to receive Heart Failure approval in November of that year, with approval to treat HFrEF patients with and without Type 2 diabetes. Aside from HFrEF, the drug is approved in Europe to treat Type 2 Diabetes and Chronic Kidney Disease.

Jardiance sales had increased 17.2% to 1.4 billion euros (USD 1.53 billion) by the middle of 2021, according to a half-year earnings report published in August by Boehringer Ingelheim. Jardiance sales in the United States totaled USD 1.49 billion for the full year. On the other hand, AstraZeneca’s Farxiga is expected to generate around USD 3 billion by 2021. 

BMS Secures a Neoadjuvant Market for Opdivo in NSCLC

Keytruda (pembrolizumab) has been the dominant PD-1/PD-L1 drug in the NSCLC market, owing primarily to its role in first-line therapy for more advanced cases, but competitors have been quicker to move into the neoadjuvant and adjuvant settings. While Bristol-Myers Squibb’s Opdivo has been the second fiddle for years, it now has a chance to shine on its own.

Opdivo (nivolumab) is the first and only cancer immunotherapy to be approved in the United States for the neoadjuvant treatment of NSCLC, which is used to shrink tumors before they are surgically removed. The goal of surgery in these NSCLC patients is curative, but between one-third and half will experience recurrence and require additional treatment.

The approval was based on the findings of Phase 3 CheckMate-816 study, which found that the combination of Opdivo and pre-surgery chemotherapy significantly improved event-free survival, with a 37% reduction in the risk of progression, recurrence, or death when compared to chemo alone. The benefit was seen regardless of PD-L1 levels, making Opdivo an option for all people with resectable NSCLC who do not require testing.

Opdivo was approved as part of the FDA’s Real-Time Oncology Review (RTOR) pilot program, which aims to expedite access to new treatments. It was also conducted as part of Project Orbis, a collaboration between the FDA and regulators in Australia, Canada, and the United Kingdom, where Opdivo is still being evaluated.

FDA Grants Breakthrough Status to Pfizer’s RSV Vaccine

Pfizer has received FDA breakthrough therapy designation to its respiratory syncytial virus (RSV) vaccine candidate, PF-06928316 (RSVpreF). The vaccine is developed to prevent RSV-associated lower respiratory tract illness in infants from birth to 6 months by active immunization of pregnant women. 

The FDA decision is based on the results of phase 2b proof-of-concept study of RSVpreF (NCT04032093) in a double-blinded, global, placebo-controlled study in healthy pregnant women aged 18 to 49 years and their infants. RSVpreF comprises two preF proteins desired to improve safety against RSV A and B. Pfizer is expected to publish the trial results in the coming months. Earlier in September 2021, Pfizer announced the initiation of another phase 3 clinical trial to evaluate the efficacy, immunogenicity, and safety of a single dose of RSVpreF in individuals aged 60 years and older.

Respiratory Syncytial Virus is a contagious virus that can affect the lungs and breathing passages. It can be potentially life-threatening for young infants, the immunocompromised, and older adults. Moreover, in the United States, Respiratory Syncytial Virus leads to nearly 50,000 hospitalizations in children under the age of 5 years. As of now, the Respiratory Syncytial Virus therapeutics market does not have any vaccine, and only supportive care is available to prevent the condition. The positive result and approval of the emerging therapies including PF-06928316 are expected to significantly improve the treatment outcome for the affected individual.

Civica Plans to Shake Up the Insulin Market with Low-cost Biosimilars

Insulin affordability is one of the major challenges in the healthcare segment. To overcome this issue, Civica has announced plans to manufacture and distribute insulins at a lower price compared to the existing market prices. Civica is a nonprofit generic pharmaceutical company with its insulin initiative aimed to push the affordability and accessibility of insulin in the US healthcare market. The Civica has collaborated with the Juvenile Diabetes research foundation (JDRF), a leading global type 1 diabetes (T1D) research and advocacy organization. 

Civica is intended to manufacture 3 insulin biosimilars. The first is Sanofi’s Lantus (insulin glargine) which is a long-acting insulin biosimilar. The other two insulin include rapid-acting insulins, one of Novo Nordisk’s Novolog (insulin aspart) and Eli Lilly’s Humalog (insulin lispro). The insulins will be available both in vials and prefilled pens. Civica intends to charge no more than $30 per vial and no more than $55 for a box of five pen cartridges. Civica is expected to complete the clinical trials, file the necessary applications for FDA approval and the availability of the first insulin (glargine) in the US by 2024. Additionally, Civica entered into an agreement with GeneSys Biologics for the co-development of three insulin biosimilars. 

Diabetes is a chronic condition that affects a significant portion of the population globally. As per DelveInsight’s “Diabetes Market” report, in the United States, around 34 million people are affected with diabetes which is nearly 10.5% of the total population. Over time Diabetes can lead to significant damage to various body parts such as the heart, eyes, kidneys, blood vessels, and nerves. Insulin therapy is crucial for diabetes treatment. Currently, insulin affordability is one of the major challenges. However, the approval of the low-cost insulins by the Civica is expected to significantly improve the affordability of the insulins and the treatment outcome for the uninsured or underinsured person.

Amgen, NHS Strike Deal to Enhance Lumykras Availability in the UK

National Health Service (NHS) struck a deal with Amgen with regard to the company’s hit lung-cancer drug Lumykras, in order to make it more available to the affected people.

The agreement accounted for Lumykras administration to 600 patients. This deal comes after 100 patients were granted access to the drug in September of last year under Project Orbis. This project was considered a collaborative effort between the United States, Canada, Australia, the U.K. drug regulators, and many other countries to speed up the approval for promising cancer treatments. 

This treatment comes as a second project under Orbis, as the first one was AstraZeneca’s Tagrisso, another lung cancer treatment drug. This project helped in giving a green flag to a variety of cancer drugs. The drug is marketed with the name of Lumakras in the US. Last May, Lumykras scored FDA approval for a specific type of non-small cell lung cancer that was earlier considered to be “undruggable.” It is used for the treatment of KRAS G12C mutation, also known as the “death star,” for its shape and resistance to treatment. This type is observed in almost 13% of NSCLC patients. The second-line treatment can be administered to patients who didn’t respond to chemotherapy previously and have fewer side effects. Another advantageous factor is its ease of administration and it can be taken in tablet form.

“It is very exciting to see this ground-breaking treatment coming into use after 40 years of research on this important target,” the NHS’s clinical director for cancer, Peter Johnson, said in a release.

Roche Begins a New Four-Year Study of the Alzheimer’s Drug Gantenerumab

The pharma giant – Roche is looking forward to a four-year Phase III study of its Alzheimer’s drug gantenerumab. This new study will be a placebo-controlled SKYLINE study with 1,250 participants aged between 60 to 80 years, with the earliest biological signs of Alzheimer’s but no cognitive impairment. The focus of this study is to see whether the anti-amyloid antibody can slow disease progression over a four-year follow-up period.

The drug received a breakthrough therapy designation from the FDA. The Swiss pharma’s Genentech unit is reported to initiate two pivotal trials of gantenerumab in the second half of the year. These two studies namely Graduate 1 and 2, constitutes for more than 2,000 patients with initial symptom appearance of Alzheimer’s Disease. The study is also supposed to test the monoclonal antibody in patients who either don’t have Alzheimer’s but are at risk or are in the earliest stages of the memory-robbing disease.

The past record of the drug isn’t much encouraging, as gantenerumab has previously failed a Phase III trial in Alzheimer’s patients who showed early signs of cognitive impairment. However, the willingness of Roche  to launch another Phase 3 trial indicates that  it is willing to play the long game, and bet more money on the drug, hoping that the role of anti-amyloid drugs will become more clear in the coming years. 

Olumiant Benefits Additive to Other Drugs in people With Severe COVID 

According to new findings from the UK RECOVERY trial, Eli Lilly and Incyte’s JAK inhibitor Olumiant reduced the death risk by 13% in hospitalized COVID-19 patients when added to other drugs. The benefit came when Olumiant (baricitinib) was added to two other anti-inflammatory drugs (steroid dexamethasone and Roche’s IL-6 inhibitor Actemra/RoActemra (tocilizumab)),  that have also been shown to boost the survival in severe COVID-19 cases, as well as Gilead’s antiviral Veklury (remdesivir).

According to the researchers, overall, 513 of 4,148 patients allocated to baricitinib versus 546 of 4,008 patients assigned to usual care died within 28 days. The finding is significant as giving the drug combined with the other therapies could save more lives in people with severe COVID-19. Olumiant could also be an alternative for areas where access to other drugs is limited.

Patients consuming baricitinib were also more likely to be discharged alive within 28 days. They were less likely to require mechanical ventilation, and there was no evidence of increased risk of infections or blood clots, all of which are possible side effects of Olumiant therapy.

The findings support Olumiant’s earlier findings in COVID-19, which showed a significant impact on mortality and led to the drug’s placement on the World Health Organization’s list of approved COVID-19 therapies earlier this year. There was limited information about the drug’s use in addition to Actemra in the earlier trials. While vaccination appears to be keeping the COVID 19 pandemic under control in the UK and many other countries, many cases remain, and the death toll continues to rise. Over the last week, there have been an average of 60,000 new points and 159 daily fatalities in the United Kingdom.

Natco Pharma Launches First Generic Drug of Revlimid

Natco Pharma, along with its marketing partner Arrow International – an affiliate of Israeli-drug maker Teva Pharmaceutical Industries, announced the first generic version of Celgene’s (now acquired by Bristol Myers Squibb) top-selling cancer drug Revlimid (lenalidomide capsules) in the United States market.

According to IQVIA data, Revlimid had annual sales of $2.3 billion as of December 2021. The generic version of Revlimid will be accessible in 5mg, 10mg, 15mg, and 25 mg strengths. The announcement came after market hours. The Shares of Natco Pharma were 2.98% to close at Rs 844.30 on Bombay Stock Exchange (BSE) on Monday; the benchmark Sensex fell 2.74% to end at 52,842.75 points.

Natco, along with Arrow International, previously settled the Paragraph IV litigation in 2015 related to the Revlimid with Celgene, which is now a part of Bristol-Myers Squibb. Adults are prescribed lenalidomide capsules to treat multiple myeloma combined with dexamethasone, certain myelodysplastic syndromes, and mantle cell lymphoma after specific previous treatment.