FDA Grants Moderna/Merck Therapy Breakthrough Status

On 22 February 2023,Moderna and its partner Merck announced that Moderna's MRNA cancer vaccine MRNA-4517/V940 and Merck's Keytruda(R) cancer therapy have been granted breakthrough therapy status by the U.S. Food and Drug Administration.That means the FDA will fast-track its review of the new combination therapy.The Moderna cancer vaccine,when administered with Merck's Keytruda(R) cancer therapy following complete surgical resection,prevented recurrence of advanced melanoma skin cancer (stage III/IV) in 44% of patients in a Phase 2b clinical trial.Preliminary breakthrough designations are given when evidence indicates that the product may demonstrate substantial improvement over available therapies on at least one clinically significant endpoint. The new therapy is given for the adjuvant (prevention of cancer returning) treatment of patients with high-risk melanoma following complete surgical resection (removal).The two companies are to begin a Phase 3 clinical trial of the novel therapy.Moderna and Merck want to investigate the new therapy as an adjuvant treatment for other forms of cancer,including non-small cell lung cancer.* Earlier,the FDA granted breakthrough status to Moderna's MRNA vaccine against respiratory syncitial virus (RSV) which proved highly effective (more than 80%) at preventing RSV in a clinical trial.RSV is a serious threat primarily to children younger than five and older adults.RSV is the leading cause of hospitalization of babies.In the US,it kills an estimated 100-500 children a year and about 14,000 adults a year,but the estimate is suspected to be lowball.* Merck & Co Inc (MRK),Moderna Inc (MRNA)

Biotech's Respiratory Virus Treatment:FDA Dissatisfied

The Food and Drug Administration has requested that biotech firm MedImmune conduct further study of its respiratory virus treatment motavizumab.MedImmune recieved a complete response letter from the FDA asking for an additional clinical trial of motavizumab that supports a satisfactory risk/benefit profile.MedImmune,the biologics unit of British drugmaker AstraZeneca,said it will thoroughly review the letter and make a decision in due course about motavizumab,which it says it continues to believe in.It was the second complete response letter it had recieved from the FDA in the course of seeking approval for the treatment.
Motavizumab is being investigated to treat respiratory syncytial virus,which poses a threat to certain infants and adults.RSV typically causes a mild cold-like illness that clears up within a few weeks,but can be more severe,causing pneumonia or bronchitis in young babies,premature babies or adults,especially those with chronic heart or lung problems-possibly leading to death and requiring hospitalization.
Motavizumab is a monoclonal antibody,which is an antibody produced by a cloned cell that binds to a targeted cell,potentially stimulating the patient's immune system to attack the target cell.
Based in Gaithersburg,Maryland,MedImmune employs about 3300 people worldwide.It also has facilities in Frederick,Maryland and Cambridge,U.K.
AstraZeneca(AZN)