Regulatory Index News: 10/04/2018

Today’s Regulatory Index News update includes positive results leading to approval for a novel treatment whilst negative phase 3 results are reported for another and China updates policy to favour generics.

Clovis' Rubraca awarded new US approval

The FDA has awarded Clovis’ Rubraca its second approval as a maintenance treatment for patients with recurrent ovarian (epithelial ovarian, fallopian tube and primary peritoneal) cancer who are in a complete or partial response to platinum-based chemotherapy. The poly(ADP-ribose) polymerase (PARP) inhibitor works by blocking the repair of damaged DNA in cancer cells leading to the death of those cells. This conversion of Rubraca to a full approval from its previous conditional approval was based upon phase 3 (ARIEL3) data which showed that it extended progression-free survival (PFS) versus placebo in all patients, regardless of their BRCA status. If you would like to read more please read the PharmaTimes article here.

Incyte and Merck’s partnered epacadostat/Keytruda combo fails melanoma trial

After positive phase 1 and 2 results in skin cancer, Incyte’s IDO1 inhibitor epacadostat and Merck’s PD-1 inhibitor Keytruda combo were hoped to be a potential improvement on the BMS’ regimen of Opdivo and Yervoy. Unfortunately, phase 3 data (ECHO-301) suggests that the combo gives no benefit to progression-free survival (PFS) in metastatic melanoma when compared to Keyruda monotherapy. This has led to the trial being halted and elevated concerns on whether IDO1 is an effective immune-oncology target. This unfortunate result has led to a huge drop (over 20%) in Incyte’s share value where they now have a difficult job to rebuild confidence for the hopeful blockbuster future. If this story interests you, please read the Endpoints article here.

New pharma policy in China promotes generics over brands

Chinese policy has taken a big step towards promoting generic over branded medicines. New policy states that certain generic companies may be eligible to be designated as a high-tech enterprise which would mean they face just 15% corporate tax rate rather than the 25% faced by other companies. On top of this, physicians will not be able to write brand name prescriptions other than in special circumstances, and even then, a pharmacist can change it to the qualified generic. The country’s State Council have also issued a decree that intellectual property protections will be altered to strengthen anti-monopoly enforcement. Each of these steps further diminish innovator drug candidate values, posing a possible threat to foreign innovative drug makers. Please click on this FiercePharma article to read more.



Max Lymbery

Date Published

10th April 2018

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