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FDA drug approvals| Actemra approved for SSc-ILD | Libtayo for NSCLC

Updated: Mar 22, 2021

US FDA approved Janssen’s Ponvory for multiple sclerosis

Janssen announced that the US FDA approved Ponvory (ponesimod) for treating patients with a relapsing form of multiple sclerosis (MS). Ponvory is a selective sphingosine-1-phosphate receptor 1 (S1P1) modulator administered once daily. The drug has shown superiority versus Aubagio (teriflunomide) in reducing annual relapses and brain lesions.

The approval is based on a head-to-head Phase 3 clinical trial. The results from the trials were:

  • Ponvory reduced annual relapses by 30.5% versus teriflunomide (Aubagio) 14 mg in patients with relapsing MS

  • 70% of patients had no relapses versus 61% in the teriflunomide arm

  • The number of new gadolinium-enhancing (GdE) T1 lesions reduced by 59%

  • The number of new or enlarging T2 lesions decreased by 56%

Ponvory is the first product to have a head-to-head trial with another oral comparator.

Roche's Actemra approved in the US for decreasing the rate of decline in pulmonary function in adults with SSc-ILD

Roche has announced that Actemra (tocilizumab) was approved for treating adult patients with systemic sclerosis-associated interstitial lung disease. Tocilizumab is the first biologic approved for this indication.

The approval is based on the focuSSced trial, a Phase III double-blind, placebo-controlled trial. The trial included 212 adults with systemic sclerosis in which Actemra did not meet the primary endpoint. But, in the patients treated with Actemra, there was less decline in the forced vital capacity (FVC), and percent predicted forced vital capacity (ppFVC).

Actemra received priority review previously for treating systemic sclerosis-interstitial lung disease.

Systemic sclerosis is a disease affecting 2.5 million people, out of which 80% may be affected by interstitial lung disease. Systemic sclerosis is an autoimmune disorder resulting in the thickening of skin and lungs. Systemic sclerosis-interstitial lung disease can be life-threatening.

Sanofi has announced that it received the US FDA approval for Libtayo (cemiplimab)

The approval is for patients with advanced non-small-cell lung cancer (NSCLC), whose tumors have high PD-L1 expression (≥50%). The drug is indicated for patients whose tumors do not express EGFR, ALK, or ROS1 aberrations. The drug is indicated when the cancer is either metastatic or locally advanced tumors that are not candidates for surgical resection.

Approval for NSCLC is the third approval for Libtayo and has earlier been approved for basal cell carcinoma and cutaneous squamous cell carcinoma.

The approval is based on the EMPOWER-Lung 1 Phase 3 trial, demonstrating the superiority of Libtayo vs. chemotherapy. The phase 3 clinical trial included 710 patients. In the trial, Libtayo reduced the risk of death by 32% versus chemotherapy. The median overall survival was 22 months in Libtayo arm compared to 14 months in patients on chemotherapy.

The approval of Libtayo makes the NSCLC space more competitive.

The drugs act by blocking the PD-1/PD-L1 pathway. Opdivo and Keytruda are the other PD-L1 inhibitors that have demonstrated similar efficacy.


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