Key Drug Approvals by The FDA and EMA in October and November 2023

Important Drug Approvals by The FDA and EMA in Q3 2023


With the increasing emphasis on providing precise and quality patient outcomes for severe diseases, along with advancements in medical technology and the integration of modern approaches such as machine learning and artificial intelligence, the drug discovery is only expected to expand more. In such scenarios, the need for stringent regulatory authorities like United States FDA and EMA play a critical role in maintaining the quality and efficacy of drugs.


Here are some recent drug approvals anticipated to further shape the medical ecosystem to offer better patient care in the coming years.


Takeda Pharmaceutical’s Novel Colorectal Cancer Treatment Drug Approved by the FDA

Cancer remains as one of the most fatal diseases with colorectal cancer  (also known as bowel cancer) being the 3rd  most commonly occurring cancer out there. To combat the increasing burden of the mortalities, Takeda Pharmaceuticals, on November 8th, 2023, received the U.S. FDA approval for FRUZAQLA™ (fruquintinib) for treating metastatic colorectal cancer. The approval is based on the data set procured from two huge Phase 3 trials, namely, FRESCO-2 and FRESCO.


It is the first chemotherapy free targeted therapy alternative for metastatic colorectal cancer irrespective of the previous types of therapies given to the patient and biomarker status. It has demonstrated significant impact in improving the survival rate and overall health of the patients.


Loqtorzi Received a Green Flag for Treating Metastatic or Recurrent Locally Advanced NPC

On 27th October 2023, Coherus and Junshi Biosciences announced that the FDA approved the application of LOQTORZI™ (toripalimab-tpzi), in combination with cisplatin and gemcitabine for the treatment of recurrent locally advanced or metastatic NPC (nasopharyngeal carcinoma). Based on the results of JUPITER-02 Phase 3 study and the POLARIS-02 Phase 2 study, it is a programmed death receptor-1 monoclonal antibody that activates the immune system to kill the tumor.


When combined with chemotherapy, Loqtorzi reduced the risk of death or disease progression by 48% which improved the progression free survival as well.


Pfizer’s ELREXFIO™ Offers Hope to Treat Blood Cancer

Pfizer, on October 13th, 2023, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) showed positive opinion to grant the marketing authorization of their targeted immunotherapy drug ELREXFIO™ (elranatamab) used for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM).


Evaluated through the EMA PRIME scheme, ELREXFIO™ is B-cell maturation antigen (BCMA)-CD3-directed bispecific antibody (BsAb) immunotherapy that is subcutaneously delivered to the patients to activate the T-cells to kill myeloma cells.


Lilly’s Omvoh to Be Used as a First-In-Class Treatment for Ulcerative Colitis

Eli Lilly and Company, a leading pharmaceutical company took the stage to reveal that on October 26th, 2023, Omvoh™ (mirikizumab-mrkz) infusion (300 mg/15 mL)/injection (100 mg/mL) got the FDA approval for the treatment of ulcerative colitis (UC) in adults. This is the first and only interleukin-23p19 (IL-23p19) antagonist for treating both moderately to severely active conditions.


Omvoh was advocated for such patients who have had past treatments that either did not work or stopped working. The approval was based on the results from the LUCENT program, that constituted a 12-week induction study and a 40-week maintenance study for continuous 52 weeks. The results after 12 weeks of administration demonstrated consistent efficacy across various cohorts of patients.


FDA Approves Santhera’s AGAMREE® (Vamorolone) for Duchenne Muscular Dystrophy

On October 26th, 2023, Switzerland based Santhera Pharmaceuticals revealed that the FDA has sanctioned the usage of Agamree (vamorolone) as an oral suspension (40mg/mL) for the treatment of Duchenne muscular dystrophy in patients aged 2 years or above. This medication binds to the corticosteroid receptors and alters their downstream activity.


The approval was based on the data collected from the phase 2b VISION-DMD clinical trial which included 121 ambulatory male participants affected from DMD, falling in an age span of 4 to 7 years. Agamree showed consistent efficacy when compared to standard corticosteroids and is expected to hit the markets by the first quarter of 2024.


UCB’s Bimzelx to be Used for Treating Plaque Psoriasis in Adults

BIMZELX® (bimekizumab-bkzx), the first and only IL-17A and IL-17F inhibitor approved drug to treat plaque psoriasis in patients received the FDA approval on 17th October 2023. Backed by the data of three Phase 3 trials, the drug displayed total and long-lasting skin clearance levels up to a year. In addition, the speed of response was rapid, with around 7 out of 10 patients getting PASI 75 at week 4 after following one dose (320 mg).


Bimekizumab is a humanized IgG1 monoclonal antibody that attaches to IL-17A, IL-17F and IL-17AF cytokines selectively and blocks its interaction with the corresponding receptor. UCB anticipates the global sales to peak at a minimum of 4 billion pounds.


Merck Received New Drug Approval for Treating Metastatic Cervical Cancer

FDA approved Merck’s KEYTRUDA® (pembrolizumab) plus chemotherapy, with or without bevacizumab, to treat patients with persistent, recurrent, or metastatic cervical cancer. The approval, received on October 13th, 2023, was based on the results of the Phase 3 KEYNOTE-826 trial evaluating KEYTRUDA plus chemotherapy (paclitaxel plus cisplatin or paclitaxel plus carboplatin), wherein the patients responded to the KEYTRUDA plus chemotherapy, with or without bevacizumab better. The trial included 617 patients with recurring metastatic cervical cancer. They received KEYTRUDA 200 mg intravenously every three weeks and displayed resistance in progression of the disease.


Myasthenia Gravis Gets New Treatment Alternative: Zilbrysq

ZILBRYSQ® (zilucoplan) by UCB, designed to treat generalized myasthenia gravis (gMG) in adult patients gained the FDA approval on October 17th, 2023. Myasthenia gravis is a chronic autoimmune disorder wherein the antibodies destroy the communication between muscles and nerves, leading to weak skeletal muscles. This novel drug is specifically designed for patients who are anti-acetylcholine receptor (AChR) antibody positive.


This drug is a subcutaneous targeted C5 complement inhibitor for gMG and the approval is based on the Phase 3 RAISE study which showcased significant improvements in comparison to placebo. UCB already has two separate medicines for gMG, each with a different mechanism of action, which demonstrates the company’s vision to cater to the unmet needs of patients.


Novavax’s Improved COVID-19 Vaccine Approved in the EU

The only protein based non-mRNA COVID-19 vaccine Nuvaxovid™, has been approved to be marketed in the European Union. This vaccine is available for individuals aged 12 years or older. The vaccine demonstrated an effective functional response against XBB.1.5, XBB.1.16 and XBB.2.3 variants. The approval was based on non-clinical data that demonstrated that the vaccine could induce a broad response to variants by stimulating both arms of the immune system. The company is working on a timely delivery of dosages on a country-to-country basis.


Valneva’s Vaccine to Prevent Chikungunya Viral Infection Approved by the FDA

On November 9th, 2023, Valneva’s first chikungunya vaccine Ixchiq gained the United States FDA approval to mitigate the rising burden of diseases associated with the viral infection. Valneva launched a single-dose, live-attenuated shot, VLA1553 for population aged 12 years or older and which is recommended for those at increased risk of exposure to the chikungunya virus.


Spread by the bite of an infected mosquito, Chikungunya is emerging as a global health threat with approximately 5 million cases reported in the last 15 years. The subtropical regions of Africa, Southeast Asia, and parts of the United States are at a major risk of infection.


The rising wave of drug approvals indicates constant progress in the healthcare landscape. The continuous collaboration between the research bodies and regulatory authorities sets the stage of a bright future, wherein the latest technologies offer an improved quality of life for many living in the remotest areas of the globe.


*At Expert Market Research, we strive to always give you current and accurate information. The numbers depicted in the description are indicative and may differ from the actual numbers in the final EMR report.

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