Wave Life Sciences stocks implode; Amarin’s VASCEPA approval; GSK seeks approval

Wave Life Sciences has recently announced the discontinuation of its drug suvodirsen, for the treatment of a rare Duchenne Muscular Dystrophy mutation. 

Duchenne Muscular Dystrophy is a progressive worsening of the skeletal and heart muscles resulting in weakness. The disorder, is due to deficient protein dystrophin, due to the mutations in the DMD gene. 

The announcement of the termination of the clinical trials of suvodirsen came after the Phase 1 open-label extension (OLE) study. The trials showed no positive changes in the expression of the dystrophin from the baseline. Thus, the company has decided to halt the two trials, the OLE study and Phase II/III DYSTANCE 51 trial.  The news led to the plunging of the stocks of Wave Life Sciences losing 53.7% t 12:56 p.m. EST on Monday as revealed by NASDAQ. On the contrary, its rival Sarepta Therapeutics has shocked the Pharmaceutical market on receiving surprising FDA-approval for its Duchenne Muscular Dystrophy drug Vyondys 53. Vyondys 53 had failed to gain FDA nod three months back when the company first filed for its approval in light of safety concerns it caused. 

Amarin Corporation has finally received success in receiving the FDA-approval for its heart pill Vascepa for efficiently reducing the risk of CV events.

The approval has the company’s stocks soared by 12-year high, bringing hopes to add millions of dollars in the company’s share. 

Vascepa, first approved by the FDA to treat high levels of triglycerides in adult hypertriglyceridemia patients, is now the first drug to receive approval from the FDA which will reduce the cardiovascular risk in patients with a high level of triglycerides, and established diabetes or cardiovascular diseases and two or more additional CVD risk factors. 

The approval was based on the successful results of the trial REDUCE-IT. The trials revealed that Vascepa efficiently reduced the number of major adverse cardiovascular events (MACE) events by 25% and deaths due to it by 20%, which is a better outcome than GSK’s fish-oil pill Lovaza. 

The pill, icosapent ethyl approved as an addition to statin therapy will now benefit millions of U.S. patients suffering from complications associated with CVD.

GlaxoSmithKline has announced the submission for U.S. approval for its experimental multiple myeloma drug belantamab mafodotin (GSK2857916). 

The decision for filing for the approval was based on the clinical study DREAMM-2 that revealed an Overall response rate of 31% with the drug in patients with relapsed/refractory multiple myeloma. 

Multiple myeloma is the second most commonly diagnosed blood cancer, after non-Hodgkin lymphoma, accounting for 1% of malignancies and 10% of hematologic cancers, as per Cancer Statistics, 2018. It is noted that BCMA [B Cell Maturation Antigen, also known as tumor necrosis factor receptor superfamily member 17 (TNFRSF17)], is highly expressed in malignant cells as compared to healthy cells.

The drug, belantamab mafodotin, is designed on a similar understanding to target BCMA protein, and if it receives an okay from the FDA will become the first drug, would become the first anti-B-cell maturation antigen (BCMA) agent to treat Multiple myeloma patients in the U.S.