Letting new drugs into the market is never easy, so only a few entries get passed the strict FDA regulations annually.
Those that do pass, though, have the potential to enrich the current drug market and make it easier for both physicians and patients to get the most out of treatments.
Regarding the types of medications that hit the market during these drug launches, all sorts of patient target groups are possible – from cancer patients, ophthalmological patients, people with chronic conditions, etc.
Also, there are always new drugs in development that can be used to tackle rare diseases, as well as chronic conditions where the current drugs administered can do with an update.
In this article, we’re going to talk about the most anticipated drug launches of 2023. There are some pretty big pharma names included here and some of the medications that they came up with are projected to reach billions in revenue.
Drugs expected to be big in 2023
There’s a vast number of drugs hitting the market next year, many of them prepared and placed for evaluation by the FDA by some of the biggest pharma names in the world, including AstraZeneca, Alexion, and Novartis.
The section below lists some of their most important entries for drug launch approval in the coming year. Some represent a novelty in the treatment of certain diseases, while others are biosimilar takes. The FDA will ensure to thoroughly test both brand-new drugs and biosimilar ones, as they’ve been doing for the most part of the past two decades.
Designed to treat rheumatoid arthritis, Upadacitinib is a JAK-1 selective inhibitor for adults who need treatment for severe rheumatoid arthritis.
The officials at AbbVie submitted this drug for evaluation on December 18, 2020, both to FDA and EMA (European Medicines Agency). The FDA let this drug pass the primary testing, and it’s pending further investigation.
Rheumatoid arthritis is a chronic inflammatory disorder that typically attacks a person’s joints but can spread further in rarer cases. The drug launches targeting patients with rheumatoid arthritis must address the question of the spreading negative effect of arthritis on organs such as eyes, skin, heart, blood vessels, and lungs, in addition to joints.
The autoimmune nature of rheumatoid arthritis means that ongoing treatment is necessary.
Developer: Alexion Pharmaceuticals
Approved to be taken into consideration by the FDA back in December 2018, Ultomiris (ravulizumab-cwvz) is designed to treat adults with paroxysmal nocturnal hemoglobinuria, or PNH, for short.
PNH represents an ultra-rare blood disorder characterized by complement-mediated destruction of red blood cells.
This disease of the blood is acquired and life-threatening. The appearance of blood clots, the destruction of red blood cells, and impaired bone marrow function characterize it.
PNH is also closely related to aplastic anemia.
Developer: AbbVie & Boehringer Ingelhelm
On March 2nd this year, the EMA gave this medicine a positive recommendation, meaning that it can get fast-tracked for approval and development.
Skyrizi (risankizumab) is indicated to treat moderate to severe plaque psoriasis in adults who are also candidates for systemic therapy.
Plaque psoriasis causes dry, itchy skin with raised patches (also called ‘plaques’) covered in scales.
There may only be a couple of patches or many. Typically, patches appear on elbows, lower back, scalp & knees.
The patches may vary in color, depending on skin color.
Developer: Aimmune Therapeutics
Green-lighted for further testing on March 18, AR-101 decreases the risk of anaphylaxis after accidental exposure to peanuts and other peanut-based foods.
The working principle and idea behind AR-101 are to expose patients to a small number of peanuts in this medication. This way, throughout their therapy, they can develop a gradual tolerance for peanuts, thus decreasing the chances of an anaphylactic shock upon accidental consumption.
Anaphylactic shock occurs minutes after exposure. The symptoms include skin reactions such as hives, redness, and swelling. Itching and tingling around the mouth and throat area are also prominent symptoms.
Some of the rarer symptoms can be feeling lightheaded, wheezing, confusion & anxiety. If these symptoms are not immediately addressed, they can lead to more serious consequences, such as collapsing or losing consciousness.
Developer: Bluebird bio
Indicated as gene therapy for sickle cell disease (SCD), LentiGlobin was approved for further testing by the FDA on December 3rd this year.
Due to the potential usefulness of this medication, the FDA and EMA granted it orphan drug status and fast-track designation for testing.
Sickle cell disease represents a group of blood disorders typically inherited from the patient’s parents. The most common subtype of this disease is sickle cell anemia.
As a result of SCD, there is an abnormality in the oxygen-carrying protein hemoglobin, which is found in the red blood cells.
This manifests itself at a molecular level through the misshapenness of red blood cells. Normal red blood cells are typically round and flexible. This enables them to move easily through blood vessels.
With sickle cell anemia, some red blood cells are shaped like sickles and crescent moons (hence the name of the disease), making them rigid and sticky.
Other common symptoms include digestive issues with diarrhea, nausea, stomach cramps, and vomiting, being the most crucial ones.
The drug launches dealing with diseases as difficult as sickle cell are often fast-tracked and given a special status.
Whether it’s rare diseases that require constant gene therapy, allergies with life-threatening implications, or simple medications for non-lethal conditions, proper and thorough testing is required for each new potential entry into the pharma market.
Two major services for the US and the EU markets, FDA and EMA, respectively, work hard to deliver the best testing for every new drug they propose.