Pharma News of 2023- The pharmaceutical industry remains an intricate and ever-evolving ecosystem, and 2023 will bring with it numerous challenges that could affect sales and revenue.
As population health becomes an increasing priority, payers, pharmacies and policymakers are seeking new strategies to tackle it. Changes may include increasing attention paid to awareness programs, value demonstration and product access.
Pharma News of 2023
1. Eli Lilly’s Donanemab-Pharma News of 2023
Eli Lilly offers an innovative immunotherapy for Alzheimer’s disease called donanemab that works by clearing away amyloid plaques in the brain. Amyloid plaques may trigger inflammation and disrupt brain cell communication, ultimately leading to neurodegeneration and death.
Donanemab successfully reduced amyloid plaques by nearly two-thirds and improved patients’ memory and cognitive performance during a Phase 2 trial, as well as starting a larger Phase 3 trial to assess whether it can slow Alzheimer’s progression. The company recently started an additional trial to assess this hypothesis further.
Lilly has developed Donanemab as an anti-ABP antibody which stimulates the immune system to attack and eliminate beta-amyloid proteins that accumulate in Alzheimer’s. Clinical trials have proven its safety and effectiveness over a number of years of development.
Donanemab stands out as an amyloid-targeting therapy with significant clinical benefits; other amyloid-targeting therapies have failed to do so. Donanemab was successful at doing just this in its Phase 3 TRAILBLAZER-ALZ 2 trial by decreasing amyloid plaques by 45% within six months of treatment!
Drug trials demonstrated that this treatment stopped dementia progression in 56% of patients after 12 months, with improvements seen in 77%. Furthermore, it helped decrease amyloid plaque formation rates as well as reduce brain amyloid protein accumulation rates.
Donanemab remains under study to ascertain its effects on other aspects of amyloidosis, such as inflammation and brain swelling. According to one study, patients with lower amyloid plaque levels had better results.
Donanemab remains a promising drug for treating early-stage Alzheimer’s disease despite recent setbacks, and results from its larger trial should become available later this year; they will support an application for full FDA approval.
Eli Lilly stock has experienced rapid appreciation over the last year, as investors hope that it may become one of the next big Alzheimer’s drugs. With net margins at 20% and attractive buyback rates of 40% or lower, this stock represents an attractive investment option.
An accelerated approval for donanemab was always going to be challenging, but it does give Indianapolis-based pharma a better chance at getting it to market sooner rather than waiting for traditional approval from FDA. That bodes well for investors who hope it can eventually receive full FDA approval and become an enormous hit.
2. Biogen’s Leqembi- Pharma News of 2023
Leqembi has received rapid FDA approval as an Alzheimer’s treatment that clears away sticky plaques in the brain. Lecanemab was developed by Eisai and Biogen in Japan and must be administered intravenously twice monthly.
Amyloid-targeting antibodies were recently approved in the U.S. and could mark a breakthrough for treatment of Alzheimer’s. These drugs work by clearing away protein amyloid deposits found throughout the brain – one of the hallmarks of Alzheimer’s.
Although clinical trials showed promising results for this medication, there are risks involved as well. There may be swelling and bleeding in the brain which could cause vision problems, seizures and death – serious side effects to consider when considering its use.
Medicare and other US insurance programs do not cover pharmaceutical trials at all; that could impede its uptake, especially if it isn’t offered free or via public-private partnership agreements.
Leqembi, priced at $26,500 per year, is more affordable than Biogen’s previous anti-amyloid antibody Aduhelm; however, its list price still far surpasses other Alzheimer’s drugs on the market and according to a congressional report set “unjustifiably high”.
However, this drug could prove invaluable for patients unable to afford or access other treatments. While its effect has shown promise in slowing cognitive decline, its safety risks make its cost-effectiveness hard to estimate.
As with other Alzheimer’s therapies, this drug carries with it the possibility of amyloid-related imaging abnormalities which may result in mild to severe swelling or bleeding in the brain, sometimes with headaches, dizziness, confusion and nausea as a side effect. These incidents should usually not be life-threatening but could potentially occur. If they do arise they could result in temporary headaches dizziness confusion nausea as side effects.
These risks and potential restrictions have led a variety of advocacy groups to address them head on. Some groups are advocating for Medicare coverage of Biogen’s drug while others demand they meet higher pricing standards in their pricing arrangements.
3. GSK’s RSV Vaccine- Pharma News of 2023
The US Food and Drug Administration’s panel of outside advisers voted on Wednesday to recommend GSK’s Arexvy RSV vaccine as safe and effective in adults 60 and over, following on from last week’s vote supporting Pfizer’s vaccine.
Both shots contain the same recombinant subunit prefusion F glycoprotein antigen in combination with an AS01E adjuvant to promote an enhanced neutralizing antibody response, intended to lower severe RSV disease severity and protect adults throughout a full RSV season.
Bloomberg Intelligence estimates the RSV vaccine market to be worth approximately $5 billion today and could surpass $10 billion by 2032, making it particularly valuable to infants and those with compromised immune systems.
RSV claims the lives of over 10,000 Americans aged 65 or older each year and an estimated 300 infants under 5. It can cause inflammation to the lungs that leads to pneumonia or other serious conditions.
Though most cases of RSV are mild, severe illnesses can often prove more hazardous and require hospitalization. People living with chronic lung or heart conditions or weak immune systems are at particular risk of suffering more serious forms of the infection which could be fatal in certain circumstances.
Pfizer’s vaccine received approval to use in both the UK and Japan earlier this year, but now faces competition in its bid for FDA approval. Priority Review status will allow FDA to speed up this process.
GSK’s RSV vaccine was recently featured in the New England Journal of Medicine and found to be 82% effective at preventing lower respiratory tract disease caused by RSV. Furthermore, its efficacy was high across several secondary endpoints such as proportion of participants with comorbidities of interest or severe disease.
The advisory committee discussed at length risks related to rare neurological disorders that could potentially be caused by this vaccine, including Guillain-Barre syndrome and an uncommon form of acromegaly called autoimmune encephalomyelitis. According to its chairperson, additional safety data are necessary before approval can be granted for this vaccination program.
4. Sarepta’s DMD Therapy- Pharma News of 2023
Sarepta’s DMD Therapy is a genetic gene therapy treatment intended to address mutations that lead to Duchenne muscular dystrophy (DMD), a muscle-wasting condition which gradually weakens and eventually leaves patients wheelchair-bound. When DMD progresses, muscles cease producing dystrophin (a protein essential for development and movement).
Without dystrophin production there will be difficulty walking, climbing stairs and standing; symptoms associated with DMD often include difficulty in doing these things as well. DMD is a rare genetic neuromuscular condition which usually strikes males only.
Sarepta’s SRP-9001 gene therapy for Duchenne was recently approved by the FDA as the first gene therapy designed to boost dystrophin production, creating an exciting new approach that may benefit patients in many ways and help enhance quality of life.
SRP-9001 was tested on 80 DMD patients in a phase 2 trial, and its manufacturer hopes to conduct another soon. Furthermore, SRP is working with Roche on an international study to test SRP in children aged 4-7 years.
SRP-9001 may help to increase dystrophin levels while also relieving other symptoms associated with DMD, such as breathing issues and heart failure. This could make a substantial difference to quality of life and potentially enable patients with DMD to outlive their peers who also have it.
SRP-9001 is currently seeking FDA accelerated approval under its Fast Track program, which permits companies to market medications based on early clinical evidence indicating effectiveness while conducting further safety and efficacy trials. Under this pathway, the company has submitted its BLA for SRP-9001 with positive results from initial trials as evidence for its efficacy and safety.
SRP-9001 remains challenged despite its rapid approval, though. Due to the drug’s high manufacturing costs and reimbursement by health insurance providers, insurers may be unwilling to cover it immediately, jeopardizing Sarepta’s financial performance and slowing sales growth.
The FDA’s recent decision to waive an advisory committee meeting for SRP-9001 could be seen as another positive sign that Sarepta may soon receive approval of an innovative gene therapy that could transform DMD treatment, setting it apart from current therapies in development and driving up sales of its stock.
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