Coming off a 2016 that saw just over 20 new drugs approved for launch by the FDA, 2017 was a marked improvement - and 2018 looks to be no different. Experts are predicting several of the medications slated for launch next year could become household names.
Many of these drugs use targeted therapy to treat life-threatening diseases. Uses range from cancer to HIV to serious allergic reactions.
Here, DrugNews discusses five of the most anticipated new drug launches for 2018, along with their designed uses and expected market impact.
This HIV cocktail drug from Gilead has completed phase 3 of clinical trials and is set for an FDA application review by February 2018. Insiders expect it will receive approval for sale soon after.
And while it hasn’t shown results greater than current HIV treatments Tivicay, Descovy, Triumeq and Juluca so far, new data is still being uncovered which could give it an edge. Most importantly, it’ll give HIV patients yet another option for fighting the deadly disease.
Analysts estimate that Bictegravir could peak at sales of over $5 billion in the coming years.
Apalutamide is a new cancer therapy drug from Johnson & Johnson targeted at treating prostate cancer. It is currently in phase 3 of clinical trials with an expected launch in 2018.
J&J bought the rights to Apalutamide from Aragon for a reported $1 billion. The drug belongs to a class called androgen receptor antagonists, which work by blocking the effects of testosterone and other hormones. They are also used to treat hyperplasia, alopecia, and hormonal disorders in women.
Apalutamide is similar to the current drug Xtandi, but is designed to be more potent with less side effects on the nervous system.
Sales of the drug are estimated at more than $1.1 billion per year in the next 5 years.
The yet-to-be-named AR101 is an exiting new drug in development from Aimmune Therapeutics designed to treat peanut allergies, the most common cause of food allergy hospitalization and death in America.
Around 6 million people in the United States and Europe are affected by peanut allergies. Each year, an estimated 125,000 people are hospitalized, and up to 200 die from the condition. However, no effective treatment or cure has been developed to date.
While this drug is still in Phase 3 of clinical trials, it is expected to receive Fast Track approval by the FDA as soon as late 2018 or early 2019 if results continue as reported.
Swiss drug maker Roche has completed clinical trials of this Hemophilia therapy and is expecting an FDA approval decision by late February of 2018. If so, it could compete with current drugs like Advate and Rebinyn.
Studies of Emicizumab were positive; with data showing it can reduce bleeding by as much as 87%. Therefore, it is expected to be a major breakthrough for patients.
Hemophilia is a rare genetic disorder that causes patients to bleed longer than normal due to a reduced ability to form blood clots.
Analysts expect Emicizumab could reach sales of around $1.8 billion per year by 2022.
This new drug from AstraZeneca has been granted Breakthrough Therapy and Priority Review by the FDA for the treatment of B Cell cancers like non-Hodgkin’s lymphoma, certain leukemia and mantle cell lymphoma. It is expected to receive approval by the early part of 2018.
Lymphomas are blood cancers that effect the white blood cells of the lymph nodes.
Acalabrutinib will join a class of drugs known as Bruton’s tyrosine kinase (BTK) inhibitors, which bind to the protein to improve the ability of B cell antigen receptors to fight pathogens. Similar drugs include Johnson & Johnson’s Ibrutinib.
Analysts believe Acalabrutinib will reach annual sales of approximately $900 million in the next 5 years.
DrugNews will continue to track the latest research, development and approval of new drugs in 2018, as well as ongoing studies and FDA warnings for currently available medications. Check back for more updates!
DelveInsight. 5 Potential Blockbuster Drugs to Watch in 2017-2018. Market Research. (November 1, 2017). Retrieved from https://blog.marketresearch.com/5-potential-blockbuster-drugs-to-watch-in-2017-2018
Carrol, J. The top 10 prospective blockbuster drug launches slated for 2018. Endpoints News. (December 14, 2017). Retrieved from https://endpts.com/the-top-10-prospective-blockbuster-drug-launches-slated-for-2018-evaluate/
Last summer, the Department of Justice unveiled the details of an ongoing lawsuit and resulting settlement against industrial giant 3M, claiming the company had furnished defective combat earplugs to millions of U.S. troops serving around the world.
The FDA enacted tough new regulations this week aimed at making sure all women who are considering implantation of the Essure birth control device fully understand all the risks and benefits before moving forward.