Mid-September Sneak Peak: Latest Drug Approvals by The FDA and EU

Latest Drug Approvals by The FDA and EU


Drug approvals play a significant role in assuring the quality of drugs within the healthcare ecosystem. From early drug discovery to pre-clinical phase to clinical phase to finally reaching regulatory approvals. Whether it is a small tablet or a complex medical device, each product goes through multiple trials and tests to ensure the quality. These drug approvals play a pivotal role in the development of the treatment landscape. While the current drug pipeline is still lengthy, some key drugs have recently been approved by the FDA and EU. Some of the most crucial drugs that have been approved are as follows:


sNDA Approval for RedHill’ Talicia® by FDA

The FDA consented the consumption for Talicia® thrice a day (as per TID regimen), which was earlier limited to two times a day only. Talicia is a leading therapy prescribed by the United States to eradicate H. pylori.


H. pylori is a bacterial infection that has been classified as a Group 1 carcinogen by the WHO. It is the strongest known threat for gastric cancer and a key risk element for peptic ulcer disease, along with gastric mucosa-associated lymphoid tissue (MALT) lymphoma. Talicia is a combination of antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (omeprazole). It is intended to address the strong antibiotic resistance of the bacteria and it is the only low-dosage rifabutin-based therapy approved for the treatment of H. pylori infection.


Ainos’ VELDONA® Gets Nod for Oral Warts Treatment in HIV-seropositive Individuals

Ainos announced that their low-dose oral interferon formulated drug VELDONA® received orphan drug designation by the FDA for treating oral warts in HIV-seropositive patients. Orphan drug designation is a special status that offers several perks, like market exclusivity upon regulatory approval, tax credits for qualified clinical trials, and the FDA application fee waiver.


Oral warts affect approximately 1.2 million HIV positive patients worldwide. It can cause immense discomfort and hinder the daily routine of a patient. As the current treatment methods for oral warts are limited, the company plans to advance the drug formulation to Phase III clinical trials to expediate the process.


GSK’s Momelotinib: For Exclusive Myelofibrosis Anaemia Relief

The FDA has approved Ozzara (momelotinib) by GSK plc as the first and only drug for treating anaemia in patients suffering from myelofibrosis in the United States.


Myelofibrosis is a blood cancer that depletes blood count, causing anemia and thrombocytopenia. Ozzara (momelotinib) is the only approved medication to treat both newly diagnosed and previously treated myelofibrosis. The FDA consent is based on the data provided from the Pivotal Momentum study, which was designed to evaluate the safety and efficacy of momelotinib, in comparison to danazol for the treatment and reduction of major manifestations of myelofibrosis in an anaemic, symptomatic, JAK inhibitor-experienced cohort of patients.


Green Flag for a New Ovarian Vaccine: AST-201

Recently, Aston Sci. announced that their ovarian vaccine AST 201 has received Phase 2 Clinical Investigational New Drug (IND) approval from the FDA.


The development was a part of the CornerStone-004 program, which is an initiative to combat women cancers. The approval is backed by a clinical trial conducted to analyze the efficacy of the vaccine administered, along with standard adjuvant chemotherapy. With this milestone, the company has also expanded its research to include another drug candidate, AST-301 for breast and gastric cancer in the Phase II trial.


Updates on COVID-19 Vaccine

Moderna Inc., revealed that the FDA has sanctioned the supplemental Biologics License Application (sBLA) for Spikevax® for ages 12 years and above. The updated COVID-19 vaccine contains spike proteins for the XBB.1.5 sub lineage of SARS-CoV-2. This facilitates prevention in individuals 6 months of age and older. Moderna will soon start shipping the doses to vaccination centers across the country, post the FDA approval.


Pfizer and BioNTech also got their COVID-19 vaccine Omicron XBB.1.5-adapted, approved under the supplemental Biologics License Application (sBLA) by the FDA. This vaccination is applicable for individuals aged 12 or above. It is designed as a single dose for most individuals older than 5. Children younger than 5 years of age might also be fit, only if they have not completed three doses of the previous vaccination.


FDA Approves BioLineRx's APHEXDA™ (Motixafortide)

BioLineRx Ltd., a company predominantly focused on specific cancers and rare diseases, got FDA’s approval for using APHEXDA™ to treat multiple myeloma, which is the second most common haematologic malignancy.


APHEXDA™ (Motixafortide), along with filgrastim (G-CSF), is given to mobilize haematopoietic stem cells towards the peripheral blood, so that they can be collected and used for subsequent autologous transplantation in patients. It is intended for subcutaneous use and will be administered through injections.


CHMP Gives a Nod to Adopt Veklury® (Remdesivir) in COVID-19 patients

Gilead Sciences Inc. received a green flag by the CHMP (Committee for Medicinal Products for Human Use) of the EMA to use Veklury® (Remdesivir) on COVID-19 having mild to severe liver impairment. The European Commission is yet to review the recommendation of CHMP. If accepted, Velkury will be the first and exclusive authorized antiviral COVID-19 treatment, that will be used on the patients dealing hepatic issues.


European Commission Granted an Approval for Pfizer’s LITFULO™

LITUFULO (ritlecitinib), an oral capsule to treat severe alopecia areata in patients as young as 12 years of age, received marketing authorization from the European Commission. The authorization is valid in Iceland, Liechtenstein, and Norway, along with all 27 member states. LITFULO is the first and only treatment that inhibits Janus kinase 3 (JAK3) selectively, along with the tyrosine kinase expressed in hepatocellular carcinoma (TEC) family of kinases.


Given the current advancements and research in the medical scenario, we can anticipate the advent of more breakthroughs in the pharmaceutical industry, that may prove to be a beacon of hope to treat resistant diseases and illnesses.


*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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