Brand-name drug makers are facing a wave of new competition from generics this summer and fall, with a host of new drugs preparing to launch in the U.S. and EU markets. Some of those launches will include major upgrades to existing medicines, while others will be brand-new treatments for some previously untreatable diseases. However, several key future launches have hit development snags that have delayed their FDA approval and could push them into 2023 or later.
The second half of 2022 is going to be an exciting time for new drug launches. From a promising treatment for Alzheimer’s disease to the first-ever HIV Treatment, these drugs have the potential to change the way we approach some of our most common and challenging health conditions. Read on to find out more about the most anticipated drug launches in Q3 and Q4.
Here’s what to expect over the next two quarters:
Donanemab Amyloidosis: Potential Blockbuster in The Making?
Donanemab by Eli Lilly is an anti-beta amyloid drug, which is expected to have a significant impact on Alzheimer’s patients by slowing down disease progression. It has the potential to become a blockbuster drug—especially if approved for prevention in high-risk Alzheimer’s patients. This is because up to 40 per cent of people with primary amyloidosis die suddenly, making it difficult to determine whether they would have lived longer without treatment.
According to Biopharma Dive, Eli Lilly has revised its timeline for filing an application with the Food and Drug Administration for approval of an experimental drug for Alzheimer’s disease; the company expects to finish by the end of this year, rather than by the end of March.
Overall, the industry’s efforts to cure Alzheimer’s disease have unfortunately been carried out under a cloud of pessimism. However, this isn’t to say that is a lost cause: there are multiple drugs in development, which could provide benefits for many patients suffering from this horrible affliction. In addition, it is likely that one of these drugs will be approved for sale in late 2022. While not “curing” Alzheimer’s disease altogether, this approval could be a breakthrough for the industry and its investors.
Trizeatide-ZHCl, A Novel GIP/GLP-1 Receptor Agonist with Potential to Treat Type 2 Diabetes
Trizeatide-ZHCl is a novel GIP/GLP-1 receptor agonist, which is being developed by Lilly as a treatment for type 2 diabetes. This drug has the potential to treat this disease by improving glucose homeostasis and suppressing glucagon secretion in the pancreas.
Trizeatide-ZHCl also has several other benefits over other diabetes drugs on the market. For example, it does not cause severe hypoglycaemia or weight gain when taken alongside insulin analogues (like sulfonylureas). In addition, it can be administered via different modes of administration: oral capsules or injections under the skin. Lilly is now paving the way for tirzepatide to expand its reach as a weight-loss medication. According to Samisha Khangaonkar, Senior Pharma Analyst at Global Data, the weight loss effect of tirzepatide, a diabetes drug, is impressive. In clinical trials, patients with T2D and obesity have shown significant weight loss when taking tirzepatide compared to other GLP-1 diabetes medications and its sales are forecasted to reach $6.8 billion in 2028.
Deucravacitinib-A Novel JAK Inhibitor for The Treatment of Psoriasis
Deucravacitinib is a novel, once-daily JAK 1/JAK 2 inhibitor that is being developed for the treatment of moderate to severe plaque psoriasis. This drug has received orphan drug designation from the FDA and European Medicines Agency (EMA).
Bristol-Myers Squibb just announced new two-year data on its experimental psoriasis drug deucravacitinib, which showed it to be an efficacious treatment for patients with moderate to severe plaque psoriasis. On Sept. 10, the company expects to hear back from the FDA about whether its drug application for deucravacitinib, an allosteric tyrosine kinase 2 inhibitors, has been approved for any disease. If so, it would be the first allostery drug of its kind approved for any condition. This is a great breakthrough for BMS, as this could be their 3rd approval this year, namely cancer drug combo Opdualag for melanoma, followed by Camzyos in April for obstructive hypertrophic cardiomyopathy. An extensive clinical trial involving over 1,200 patients demonstrated that 6 mg of deucravacitinib administered once daily was effective in maintaining clinical response for up to two years. BMS forecasts sales of $4 billion in 2029.
In other cases, these new drugs will serve as an alternative to existing treatments with fewer side effects or an improved safety profile than existing therapies.
Lenacapavir – A First-In-Class Nucleotide Analog Protease Inhibitor for HIV Treatment
Lenacapavir by Gilead Sciences, Inc., an investigational drug being studied to treat and prevent HIV infection, belongs to the group of drugs called capsid inhibitors. Capsid inhibitors interfere with the protein shell that protects HIV’s genetic material and enzymes needed for replication. This prevents HIV from multiplying and can reduce the amount of HIV in the body. Lenacapavir may work against strains of HIV that are resistant to other anti-HIV drugs.
Lenacapavir is in Phase 2/3 development for HIV treatment and Phase 3 development for HIV prevention. Previously The FDA had placed a clinical hold on Gilead’s injectable lenacapavir in borosilicate vials, following a vial compatibility issue. The FDA removed the hold in May 2022 after reviewing Gilead’s comprehensive plan and data demonstrating that the product could be used safely with an alternative vial made from aluminosilicate glass.
Resuming all the activities in the clinical studies to evaluate injectable lenacapavir for HIV treatment brings Gilead Sciences one step closer to its goal of offering therapeutic options for the diverse communities affected by HIV in the nearest future.
European Medicines Agency’s Committee adopts a positive opinion approving Lynparza for targeted breast cancer therapy
Some of those new approvals will include major upgrades to existing medicines. For many diseases, the recently approved medicines will offer incremental improvements over existing treatments. For example, AstraZeneca’s (AZN) Lynparza (olaparib) is a BRCA-mutated ovarian cancer drug that could be used as a first-line treatment for ovarian cancer patients who previously had not been able to take chemotherapy because of their risk of developing breast cancer. Lynparza, which was developed in association with U.S.-based Merck (MRK.N) and received approval in the United States in 2013, has been prescribed in combination with endocrine therapy as a treatment for early-stage breast cancer that has a specific type of genetic mutation.
Enhertu endorsed by European Medicine Agency for HER2-positive Breast Cancer
Enhertu, a drug developed jointly with Japan’s Daiichi Sankyo, was approved by the European Medicines Agency for treating an aggressive form of breast cancer characterized by a high rate of HER2.
Enhertu is expected to be a major growth driver for AstraZeneca, with some analysts forecasting peak sales of $10 billion. The drug is also likely to be approved this month for patients with low levels of HER2 following the recent success of a trial.
What do all these drug launches mean for the pharma industry as a whole? Some of the upcoming launches are expected to yield blockbuster sales. Others, though, might only make an impact in niche markets. Either way, they’re indicative of how pharma companies will move forward in the coming years. Pharmaceutical innovation is one of the most exciting areas of healthcare research today; the amount of money being spent on R&D is only likely to continue climbing from here. That’s a bright prospect for 2022, and beyond.