Merck & Co., Gilead, and Roche Lead Pipeline News

A roundup of the latest market developments from the pipelines of the pharmaceutical majors, featuring news from Merck & Co., Gilead Sciences, Roche, AbbVie, and Johnson & Johnson.

Editor’s Note: This article was updated on a continuous basis for news announced from Wednesday, April 25, 2018 to Tuesday, May 1, 2018.

FDA Grants Priority Review to Merck & Co. for New Use of Keytruda in Lung Cancer  
The US Food and Drug Administration (FDA) has accepted Merck & Co.’s supplemental biologics license application (sBLA) for Keytruda (pembrolizumab), the company’s anti-PD-1 therapy. The application seeks approval for Keytruda in combination with Eli Lilly and Company’s Alimta (pemetrexed) and platinum chemotherapy (carboplatin or cisplatin) as a first-line treatment for patients with metastatic nonsquamous non-small cell lung cancer.

Keytruda is one of Merck & Co.’s top-selling drugs with 2017 revenues of $3.8 billion. Keytruda is indicated for treating various cancers: unresectable or metastatic melanoma; locally advanced or metastatic urothelial carcinoma; head and neck cancer; classical Hodgkin lymphoma; certain forms of gastric cancer; and microsatellite instability-high cancer.

The FDA has granted priority review to this sBLA and has set a Prescription Drug User Fee Act, or target action, date of September 23, 2018.

Source: Merck & Co.

EMA Advisory Committee Recommends Gilead’s Biktarvy
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), has recommended Gilead Sciences’ marketing authorization application for Biktarvy (bictegravir 50 mg/emtricitabine 200mg/tenofovir alafenamide 25mg; BIC/FTC/TAF), a once-daily single tablet regimen (STR) for treating HIV-1 infection in adults without present or past evidence of viral resistance to the integrase class, emtricitabine or tenofovir.

The CHMP’s recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for use in the 28 countries of the European Union, Norway, Iceland, and Liechtenstein. A European Commission decision is expected in mid-2018.

BIC/FTC/TAF was approved by the US Food and Drug Administration on February 7, 2018.

The drug is projected by some analysts as a potential blockbluster. A recent analysis by Clarivate Analytics projects sales of $2.282 billion in 2019 and reaching sales of $3.716 billion by 2022. The launch is expected to help Gilead gain market share from GlaxoSmithKline’s (GSK) HIV regimens based on the once-daily integrase inhibitor, Tivicay (dolutegravir), which includes GSK’s Triumeq (dolutegravir /lamivudine/ abacavir), which was launched in 2014.

Source: Gilead Sciences

EMA Advisory Committee Recommends New Use for Roche’s Cancer Drug Perjeta
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Roche’s Perjeta (pertuzumab) in combination with Roche’s cancer drug Herceptin (trastuzumab) and chemotherapy (the Perjeta-based regimen) for post-surgery (adjuvant) treatment of adult patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer at high risk of recurrence.

Perjeta is a medicine that targets the HER2 receptor, a protein found on the outside of many normal cells and in high quantities on the outside of cancer cells in HER2-positive cancers. Perjeta is designed specifically to prevent the HER2 receptor from pairing with other HER receptors (EGFR/HER1, HER3 and HER4) on the surface of cells, a process that is believed to play a role in tumor growth and survival, according to information from Roche.

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.

A final decision regarding the approval of the Perjeta-based regimen, along with the full details of the approved indication, is expected from the European Commission in the near future, according to Roche.

Source: Roche

AbbVie Files for EMA Approval of New Drug Risankizumab for Plaque Psoriasis
AbbVie has submitted a marketing authorization application to the European Medicines Agency (EMA) for risankizumab, an investigational interleukin-23 (IL-23) inhibitor, being evaluated for treating patients with moderate-to-severe plaque psoriasis.

Risankizumab is designed to selectively block IL-23 by binding to its p19 subunit, according to information from AbbVie. IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases, according to information from AbbVie.

Risankizumab is part of a collaboration with Boehringer Ingelheim, with AbbVie leading future development and commercialization of risankizumab globally.

Source: AbbVie

 J&J’s Actelion Files to FDA for New Use of Hypertension Drug Opsumit
Actelion Pharmaceuticals, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, has submitted a supplemental new drug application (sNDA) to the US Food and Drug Administration (FDA) seeking to expand the indication of Opsumit (macitentan) to include the treatment of adults with inoperable chronic thromboembolic pulmonary hypertension to improve exercise capacity and pulmonary vascular resistance (PVR).

Opsumit is an orally active endothelin receptor antagonist that is currently approved in the US for treating pulmonary arterial hypertension to delay disease progression and hospitalization.

In June 2017, Johnson & Johnson acquired Actelion for $30 billion, which added to Janssen’s portfolio of in-market medicines and late-stage compounds and provided a rare-disease focus with pulmonary hypertension as a therapeutic area of focus.

Source: Actelion Pharmaceuticals

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