Eisai, Roche, Allergan, and Merck & Co. Lead Pipeline NewsBy
A roundup of the latest drug pipeline news, including from the pharmaceutical majors, featuring news from Eisai, Roche, Allergan, and Merck & Co.
Editor’s Note: This article was updated on a continuous basis for news announced from Wednesday September 27, 2017 to Tuesday, October 3, 2017.
FDA Accepts sNDA for New Use for Eiasi’s Cancer Drug Lenvima
The US Food and Drug Administration (FDA) has accepted for review an additional indication for Eisai’s Lenvima (lenvatinib) for treating hepatocellular carcinoma (HCC). Lenvatinib for the treatment of HCC is designated as an orphan drug by the FDA.
Lenvima is already approved in the US for treating refractory thyroid cancer.
FDA Grants Roche’s Cancer Drug Perjeta Priority Review
The US Food and Drug Administration (FDA) has accepted Roche’s supplemental biologics license application (sBLA) and granted priority review for its cancer drug, Perjeta (pertuzumab), in combination with its top-selling cancer drug, Herceptin (trastuzumab), and chemotherapy (the Perjeta-based regimen), for post-surgery treatment of HER2-positive early breast cancer (eBC).
The FDA is expected to make a decision on approval by January 28, 2018.
The combination of Perjeta, Herceptin, and chemotherapy is licensed as a neoadjuvant (before surgery) treatment for people with HER2-positive eBC in more than 85 countries worldwide following approvals by the European Medicines Agency and the FDA, under which the regimen is currently available in the US under the FDA accelerated approval program. This sBLA seeks to convert the current accelerated approval to full approval in the US. Perjeta in combination with Herceptin and docetaxel chemotherapy is also approved in the US and the European Union for people with previously untreated HER2-positive metastatic breast cancer.
FDA Accepts Allergan’s Pneumonia Drug Avycaz for Priority Review
The US Food and Drug Administration (FDA) has accepted a supplemental new drug application (sNDA) for Allergan’s pneumonia drug, Avycaz (ceftazidime and avibactam), for priority review.
The sNDA filing seeks to expand the current indications for Avycaz to include hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia (HABP/VABP) in adult patients. The FDA granted priority review status to the application based on the previous qualified infectious disease product designation for Avycaz and is expected to take action on the filing in the first quarter of 2018.
Pending the sNDA approval, this will be the third indication for Avycaz. Avycaz was first approved in Feburary 2015 in the US for treating adult patients with complicated intra-abdominal infections, in combination with metronidazole, and complicated urinary tract infections, including pyelonephritis, caused by designated susceptible bacteria, including certain Enterobacteriaceae and Pseudomonas aeruginosa.
Merck & Co. Discontinues Two Hepatitis C Combo Therapies
Merck & Co. has discontinued the development of the investigational combination regimens MK-3682B (grazoprevir/ruzasvir/ uprifosbuvir) and MK-3682C (ruzasvir/uprifosbuvir) for treating chronic hepatitis C virus (HCV) infection.
This decision was made based on a review of available Phase II efficacy data and in consideration of the evolving marketplace and the growing number of treatment options available for patients with chronic HCV infection, including Merck & Co.’s Zepatier (elbasvir and grazoprevir), according to Merck & Co. Zepatier, an oral treatment, had 2016 sales of $555 million. It is indicated for treating chronic HCV genotype 1 or 4 infection in adults for use with ribavirin in certain patient populations.
There are several other new oral hepatitis C single-agent and combination therapies. Gilead Sciences’ hepatitis C product which consist of Harvoni (ledipasvir 90 mg/sofosbuvir 400 mg), Sovaldi (sofosbuvir 400 mg), and Epclusa (sofosbuvir 400 mg/velpatasvir 100 mg), had 2016 sales of $14.8 billion. AbbVie has three oral hepatitis C drugs: Viekira (dasabuvir, ombitasvir, paritaprevir, and ritonavir) with 2016 revenues of $1.18 billion; Technivie (ombitasvir, paritaprevir and ritonavir) for use in combination with ribavirin for HCV genotype 4 infections; and Mayvret (glecaprevir/pibrentasvir), which was approved by the FDA in August 2017. Bristol-Myers Squibb also has an oral HCV drug, Daklinza (daclatasvir), which was approved in July 2015, and had first half 2017 sales of $158 million.
Source: Merck & Co.