Coming up with a new drug that can help save lives or at least alleviate the symptoms of patients worldwide is a noble pursuit with a tough road ahead.
Getting a drug approved is justifiably rigorous and arduous, as the lives of people taking the drugs can get significantly affected by them – for better or worse. The FDA’s task is to ensure that an approved drug can affect the patient only for the better – 100% of the time.
Thanks to their strict testing standards, the FDA will let only the best, most well-proven drugs past their testing facilities and into the market.
In this article, we will talk about the new FDA drug approvals in 2022. Here are some of the most important new introductions into the drug market.
Drugs recently approved by the FDA
FDA is an organization held in high esteem and with vast experience in testing food and medication safety. Through their rigorous standards, they have tested and approved numerous medications during the last two decades alone.
In 2022, the FDA drug approvals were busy approving quite a few different drugs for treating diabetes, cancer, and many other diseases. Other than testing and approving brand-new drugs, the FDA also included novel indications for already-existing drugs this year.
Below is the list of some of the most notable entries of 2022:
Date of approval: November 14
Produced by ImmunoGen Inc., Elahere is an injection used for treating ovarian, fallopian tubes, and peritoneal cancer. The name of this injection is ‘mirvetuximab soravtansine-gynx’. It’s a folate receptor alpha that serves the purpose of a directed antibody and microtubule inhibitor conjugate.
The prerequisite for starting treatment with Elahere is taking at least one to three prior treatment regimens. It is indicated for adults.
Ovarian cancer is a type of cancer affecting the ovaries. Ovaries produce eggs for reproduction as well as critical hormones estrogen and progesterone. Ovarian cancer cells can multiply quickly and start destroying the surrounding healthy tissue.
Representing one of the rarest forms of reproductive organ cancers, fallopian tube cancer only affects 1,500 to 2,000 people worldwide. It affects the fallopian tube, which connects the ovaries with the uterus.
Another rare form of peritoneal cancer affects the peritoneum – a thin sheet lining the inside of the abdomen, covering the uterus, and extending over the bladder and the rectum.
Date of approval: October 22
Made by AstraZeneca, the Imjudo injection is a treatment for hepatocellular carcinoma. It’s chemical name is ‘tremelimumab-actl’ and it is a CTLA-4 antibody designed to work as a blocker in conjunction with durvalumab (Imfinzi). The target patients for this medicine are patients with uHCC (unresectable hepatocellular carcinoma).
Mostly occurring in people with already-existing common liver diseases such as hepatitis-caused cirrhosis, uHCC is the most commonly-found type of liver cancer. Liver treatment injections are common candidates for FDA drug approvals trials.
Date of approval: October 7
Developed by scPharmaceuticals Inc., Furoscix (furosemide) injection is a treatment for heart failure. It represents a loop diuretic that is used for treatment at home in case of a heart congestion due to fluid overload.
This injection is developed for adult patients suffering from NYHA Class II or III chronic heart failure.
Patients with Class II cardiac disease have a slight limitation of physical activity due to their condition. Ordinary and especially vigorous physical activity results in palpitations, tiredness, and shortness of breath.
Patients with Class III cardiac disease are comfortable at rest. Any form of physical exertion or activity can cause angina pain, fatigue, palpation, dyspnea, and other discomforts.
Date of approval: September 30
Produced by Taiho Oncology, Inc., the Lytgobi (futibatinib) is made in the form of tablets. It is used to treat cholangiocarcinoma, a rare form of cancer affecting the bile ducts in the stomach. Cancer cells attach themselves to the insides of the stomach tubes that connect the liver, gallbladder, and small intestine.
These tablets function by inhibiting FGFR 1, 2, 3, and 4. The changes in DNA of the cells lining the walls of the stomach is the primary cause of cholangiocarcinoma. As the DNA of the cell changes, the instructions that the affected cells receive no longer match the needs of the body but instead reproduce out of control.
This way, the cancerous mass grows and can block or otherwise negatively affect the surrounding tissue.
Date of approval: September 27
Made by Harrow, Iheezo (chloroprocaine hydrochloride) comes as a gel used for ocular surface anesthesia.
Ophthalmic gels are one of the most common types of ocular anesthesia used regularly in ophthalmic surgeries. As such, it represents one of the simpler alternatives to general anesthesias, which are used only for more complex procedures.
In particular, ophthalmic gels are used for ocular surgeries where patient cooperation is necessary. FDA drug approvals regularly test gels and other surface anesthetics that can be used in eye surgeries such as cataract removals, glaucoma surgeries, corneal transplants, enucleation, strabismus repairs, vitreoretinal surgeries, and others.
Date of approval: September 22
Developed by Santen Inc., Omlonti (omidenepag isopropyl) is an ophthalmic solution that reduces elevated intraocular pressure in patients suffering from ocular hypertension or open-angle glaucoma.
FDA drug approvals for gels and solutions for eye-related problems are fairly commonplace, and there are a couple of them in 2022.
Open-angle glaucoma is a subset of glaucomas defined by an otherwise open, normal-looking angle of the anterior chamber but with raised intraocular pressure. This set of glaucomas is considered open-angle glaucoma if no underlying disease is present.
As more and more new treatment methods and pills are being discovered and produced, rigorous and careful testing has never been more important.
The work done by the FDA not only keeps the standards of the pharma industry high, but it also helps pharma experts hone their skills and keep the patients safe and the medical professionals equipped with the most cutting-edge potent drugs.