Four New Drugs Keeping the FDA Busy Today


Despite a global pandemic, the show must go on for the drug development world. Here are five companies submitting applications for new drugs to the FDA this week. 

Altimmune’s AdCOVID 

Altimmune has taken a unique approach to a COVID-19 vaccine with a single-dose nasal spray candidate. With promising preclinical data, the Gaithersburg company has submitted an Investigational New Drug application (IND) to the FDA to allow a Phase I study of its vaccine, AdCOVID.  

With one COVDI-19 vaccine approved for EUA, another approval-imminent and more getting close to submission, it may seem a bit fruitless for companies to continue pushing into the clinic for more COVID-19 vaccine trials. Altimmune’s approach may still prove valuable. 

Professor Frances Lund said that it’s not yet clear if mucosal immunity is vital to preventing the transmission of SARS-CoV-2. This means that potentially, even after receiving an intramuscular vaccination, the nasal cavity could still be a reservoir for COVID, carrying it, spreading it and infecting those without immunity. 

Alitmmune’s CEO, Vipin Garg says his vaccine has benefits the others don’t. For example, ease of transport at room temperature and basic refrigerator storage makes much broader distribution possible. As a nasal spray, it’s an ideal form for administering to children. 

The company is on track to begin Phase I this year with a data readout available in the first quarter of 2021. 

Amgen’s Sotorasib 

With cancer as the number 2 killer globally, the FDA has launched a Real-Time Oncology Review pilot, aiming to speed up the approval of new cancer drugs to bring lifesaving treatments to patients faster. Sotorasib fit the bill for the pilot and has been submitted for approval to treat non-small cell lung cancer (NSCLC).  

Sotorasib is a KRAS-targeting medication. Roughly 13% of NSCLC patients carry KRAS G12C mutations. It’s also linked to up to a third of all cancers. Even with decades of research, KRAS has been a tough nut for pharma to crack due to a lack of small-molecule binding pockets. Amgen’s drug has proved itself to be the first small molecular inhibitor that specifically binds to the mutant protein in KRAS, turning off the signal it sends to trigger cell division and cancer cell growth.  

The FDA granted sotorasib Breakthrough Therapy designation for patients with locally advanced or metastatic NSCLC, following at lesat one prior systemic therapy. 

Amgen filed the NDA based on the results of the CodeBreaK 100 clinical trial in 126 NSCLC patients that were KRAS G12C-positive. The drug curbed tumor growth in 88% of patients and shrank tumors in a third of them.  

Amgen will continue to run more studies on the drug, pitting it against docetaxel chemo in NSCLC patients and combining it with combinations of other drugs for other KRAS-driven cancers. 

AlloVir’s ALVR106 

Massachusetts-based AlloVir is developing allogeneic, off-the-shelf Virus-Specific T Cell (VST) therapies for 12 different, globally devastating viruses. Today the company’s Investigational New Drug application for candidate ALVR106 was cleared by the FDA. 

ALVR106 is designed to target infections and diseases caused by respiratory syncytial virus (RSV), influenza, parainfluenza virus and human metapneumovirus. Respiratory tract infections due to these viruses are a major public health concern, which, when progressed to the lower respiratory tract, has a mortality rate of 20-45%. 

The FDA’s approval will allow AlloVir to begin a Phase I/II proof-of-concept clinical study in allogeneic and autologous hematopoietic stem cell transplant (HSCT) patients with respiratory infections caused by RSV, influenza, PIV or hMPV.  

“Respiratory viruses are a leading cause of morbidity and mortality in HSCT patients, and based on evidence from our preclinical studies, we believe ALVR106 could transform the treatment and prevention of respiratory infections and substantially reduce the associated morbidity and mortality of these infections in the future,” said Ercem Atillasoy, M.D., Chief Regulatory and Safety Officer of AlloVir. “The clearance of the IND for ALVR106 advances our third program into clinical trials further exploring the power of our proprietary virus-specific T cell therapy platform.” 

Takeda’s TAK-721 

The FDA grants Priority Review to applications of drugs that have the potential to bring significant improvements to patients over existing treatments. This designation accelerates the review timeline to 6 months, compared to the 10 months of a standard review.  

Takeda submitted their NDA for investigational therapy budesonide oral suspension, TAK-721, today and was granted the accelerated Priority Review designation.  

TAK-721 is aimed at treating eosinophilic esophagitis (EoE), a chronic inflammatory disease that damages the esophagus. While the cause of the disease remains unknown, it currently affects 1 of every 2,000 Americans with increased numbers anticipated. 

Patients have limited choices to deal with the condition. If approved, TAK-721 would be the first treatment approved by the FDA for the treatment of EoE. The company plans to use the trade name Eohilia once approved to market.  


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