With an eye on promoting biosimilar competition, the FDA took the first step this week to transition its Purple Book from a listing of approved biologics and biosimilars to a searchable database. The agency launched the first phase of the database, which enables users to search for specific biologics, either by brand or nonproprietary name. Not all approved biologics were in the new database as of Monday, Feb. 24, but those with approved biosimilars appeared to be included in the launch. That fits with one of the agency’s stated goals for the digitized database. “Providing stakeholders with more information about biological products through a modernized platform should better facilitate the acceptance and use of existing biosimilar products and the development of new ones, potentially leading to lower costs for patients,” FDA Commissioner Stephen Hahn said. When “Humira” was entered in the new database, the search returned a page topped with all the adalimumab biosimilar approvals and links to their label information, even though none of the biosimilars will be available in the U.S. until 2023. The user had to scroll to the bottom of the page to get to the information for Abbvie Inc.’s Humira itself. (The links to label information went to each drug’s listing on the Drugs@FDA database.) The FDA said it will be opening a docket for public feedback to inform the next phases of the Purple Book development. The FDA also recently launched a new resource to help researchers collect historical information about the agency’s drug and biologic approvals. The online compilation contains curated data about new molecular entities (NMEs) approved by the Center for Drug Evaluation and Research since 1985. The compilation will consolidate information for each NME approval, with data from FDA internal databases and document records.
The FDA is asking the Oncologic Drugs Advisory Committee (ODAC) to weigh the benefits vs. the risks of two treatments for prostate cancer and metastatic non-small-cell lung cancer (NSCLC). In a double-header Wednesday, Feb. 26, ODAC will review the data for Luxembourg-based Steba Biotech SA’s new drug application for Tookad (padeliporfin di-potassium) as a treatment for localized early stage prostate cancer. Some of the questions FDA reviewers raised include whether study endpoints and their results were adequate to characterize the benefit and whether uncertainties around the trial data allow for a reasonable overall assessment of risk/benefit. Later in the day, the committee will discuss Indianapolis-based Eli Lilly and Co.’s supplemental biologic license application for Cyramza (ramucirumab), to be used in combination with erlotinib as first-line treatment of metastatic NSCLC with tumors that have epidermal growth factor receptor exon 19 deletions or exon 21 substitution mutations. While the drug met its primary endpoint of improved progression-free survival in the RELAY trial, the FDA has some questions about its effect on overall survival. First approved in 2014 to treat stomach cancer, Cyramza was approved a month later as second-line treatment for NSCLC.
The FDA finalized a 2019 draft guidance specifying that all type III drug master files (DMFs) will qualify for an exemption from submission in electronic common technical document (eCTD) format, in addition to the current exemption for noncommercial investigational new drugs (INDs). The agency also will grant long-term waivers from the requirement to submit DMFs in eCTD format for certain positron emission tomography (PET) drugs and type II DMFs that only support PET drugs or noncommercial IND applications. Under extraordinary circumstances, the FDA may grant a short-term waiver from the eCTD requirement. The guidance discusses how to submit a waiver request.
As part of its commitment to expand the use of real-world evidence (RWE) in its value assessments of therapies, the Institute for Clinical and Economic Review (ICER) is partnering with New York-based Aetion Inc. to generate decision-grade RWE. “Aetion’s rapid-cycle analytics will enable us to quickly generate evidence with the needed rigor and transparency to include in our reviews,” ICER’s Chief Scientific Officer Pamela Bradt said. “Through this partnership, we aim to set new standards for how RWE can better inform the consequential decisions that biopharma manufacturers, insurers and other stakeholders make every single day around drug pricing and patient access.” ICER will use the Aetion Evidence Platform to generate RWE for select upcoming assessments and 24-month re-evaluations. The protocols that are developed will be included in the assessments that are publicly released, enabling other stakeholders to replicate the studies.
The U.S. SEC temporarily suspended trading of Eastgate Biotech Corp. (OTC Link:ETBI), of Toronto, citing concerns about “the adequacy and reliability of publicly available information” about the company. One concern involves information about the company’s purported international marketing rights to an approved coronavirus treatment with potential to be used against COVID-19. Disclosures the company made in its Sept. 30, 2019, quarterly report about issued and outstanding shares also raised concerns, according to the SEC.
A second Pixarbio Corp. official was sentenced last week in connection with a scheme to defraud investors and manipulate the company’s shares, according to the U.S. Attorney’s Office for the District of Massachusetts. Jay Herod was sentenced to six months in prison and three years of supervised release with 400 hours of community service per year. He also was ordered to pay forfeiture/restitution of $120,000. Earlier this month, Herod pleaded guilty to one count of securities fraud and one count of obstruction of an agency proceeding and agreed to cooperate with the government. He admitted that, beginning about December 2016, he engaged in manipulative trades intended to stimulate market demand for Pixarbio stock and artificially inflate its price and trading volume. The trades included overlapping orders to buy and sell company shares at the same price per share and small purchases submitted shortly before the market closed that were intended to boost the closing price. Herod shared his trading proceeds with the company and Pixarbio CEO/founder Frank Reynolds. He also admitted that he made materially false statements to the SEC and provided a back-dated document with the intent to obstruct the SEC’s investigation. Reynolds was sentenced Feb. 18 to seven years in prison and ordered to pay $280,000 in forfeiture and about $7.5 million in restitution.