Brexit referendum slowing the European Medicines Agency’s operations to a crawl.

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The News:

The European Medicines Agency (EMA) recently addressed its concerns for ensuring business continuity and staff retention which had become huge challenges caused by the Brexit referendum. The EMA previously announced that it expected “significant staff losses” of around 30% of its workforce during the relocation to Amsterdam. Officials reiterated that the primary goal for the EMA’s Brexit task force had been to ensure it remained operational, “even if we encounter considerable staff losses.”

In terms of the size of staff losses, EMA officials stated that the annual turnover is “comparable” to previous years but they noted that the larger portion of employees would leave the agency during the first half of 2019.

Guido Rasi, the EMA’s executive director, outlined exactly where the agency had curbed non-core activity:

“A concrete example that underlines this point is the is the delay the update of our guidelines on the development of new medicines to treat hemophilia A and B. There are exciting new developments based on novel therapies underway. However, we had to temporarily stop the revision of the current guidelines to be able to concentrate on Brexit and relocation,” Rasi explained.

He also noted that the agency has not been able to continue its efforts to proactively publish clinical trial data, and the additional strain that has been placed on its IT systems have caused delays on the potential upgrades to the system.

As a result, Rasi warned, “we cannot rule out a longer-term impact on this agency unless the commitment is made to invest the necessary resources again in the future.” (Ref: in-Pharma

Here are the highlights of last week’s regulatory action spanning drugs and devices by the FDA, EMA and Japan. As you’ll note, the FDA is firing on all cylinders while the EMA had its fourth consecutive week with just one or zero actions.

1) The US Food and Drug Administration has extended the indication for the glucose-lowering drug liraglutide (Victoza) from Novo Nordisk A/S (Bagsvaerd DNK) to include patients as young as 10 years of age, making it the first noninsulin drug approved for treating pediatric type 2 diabetes in almost 20 years. Liraglutide, a subcutaneous injectable glucagonlike peptide–1 receptor agonist, has been available for treating adults with type 2 diabetes since 2010. It is the first drug other than insulin to be approved specifically for treating youth with type 2 diabetes since metformin was approved for pediatric use in 2000. Although type 2 diabetes was previously considered a condition primarily of older adults, incidence has been increasing in young adults and children.

2) Elsewhere, Zebra Medical Vision Ltd. (Tel Aviv), a medical imaging analytics company, said it received its third clearance from the FDA for its alert for intracranial hemorrhage, based on head CT scans. The latest cleared product uses artificial intelligence to automatically identify suspected internal brain bleeds based on head CTs. This can significantly reduce turnaround time and increase the radiologists’ confidence in their diagnosis, Zebra said. Its product for pneumothorax chest X-rays received FDA clearance in May. Intracranial hemorrhage accounts for about 10% to 20% of all strokes, and can occur as a result of traumatic injury, ruptured arteries, stroke or cancer.

3) The FDA has approved Merck & Co.’s (Kenilworth, NJ) Keytruda as a monotherapy for small cell lung cancer (SCLC) patients who have failed platinum-based chemo and at least one other line of therapy, Merck said. Similar to Bristol-Myers Squibb Co.’s Opdivo’s third-line FDA approval last August, the new Keytruda nod was granted under the accelerated approval program based on tumor response rate and duration of response data. In pooled data from the Keynote-158 and Keynote-028 non-randomized trials, which enlisted 83 metastatic SCLC patients who had failed two or more lines of treatment, Keytruda provoked a response in 19% of participants. Among the 16 who responded, 63% of their tumors continued to respond to Keytruda for a year or longer, according to Merck.

4) Roche Holding AG (Basel CHE) received accelerated FDA approval for its drug Polivy to treat patients with relapsed/refractory diffuse large B-cell lymphoma. About 40% of patients in the Phase 1b/2 study obtained a complete response when given the Polivy combination regimen, compared to only 18% with bendamustine plus Rituxan (BR) alone. Roche’s Phase 2 study was positive in that Gazyva given alongside standard of care achieved superior complete renal response when compared to placebo plus standard of care.

5) Alexion Pharmaceuticals Inc.’s (Cambridge MA) successor drug Ultomiris has secured a priority review from the FDA to treat atypical hemolytic uremic syndrome (aHUS), an ultra-rare disease that can cause progressive damage to vital organs, the drugmaker said Thursday. The FDA’s approval decision date is Oct. 19. In its move from an ultra-rare disease company to one focusing on less-rare diseases, Alexion is attempting a branding and pricing makeover. But the drugmaker still wants to back up blockbuster Soliris, and it needs a few ultra-rare indications similar to Ultomiris to do so.

6) Melinta Therapeutics Inc. (New Haven CT) said its approved antibiotic Baxdela had been granted priority review for use in community-acquired bacterial pneumonia (CAPB). The FDA is expected to make its decision by October 24. Shares of the drugmaker rocketed 198% on the week to 5.03 as a result.

“We view this move as overdone, given Baxdela approval and launch in CABP by ‘20 should have been largely baked-in and therefore is a non-catalyst. Furthermore, CABP contribution to sales is expected to be modest and unable to offset flat revs in the approved ABSSSI indication,” Jefferies analyst David Hoang said.

7) Japan’s Daiichi Sankyo Co. said the FDA has declined to approve its drug quizartinib as a treatment for adults with a type of blood cancer. The decision follows an advisory committee meeting where independent advisers to the agency voted 8-3 against the drug’s approval to treat acute myeloid leukemia patients with a specific genetic mutation called FLT3. Several experts in the committee concurred that the data presented by the company were not strong enough to support an approval and called for further study. Daiichi said it would evaluate FDA’s complete response letter and determine next steps in the US.

8) The FDA has announced a recall of the Advance Enforcer 35 Focal-Force Percutaneous PTA Balloon Catheter 6 mm x 4 cm (Cook Inc), because of reports of the balloons bursting below the rated burst pressure. The FDA has identified this as a Class I recall, the most serious type of recall, indicating a risk for serious injury or death. The recalled catheters are used for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, renal, popliteal, infrapopliteal, femoral, and iliofemoral, as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

9) Across the Pond, AstraZeneca PLC (London) said its cancer medicine Lynparza was approved as a first-line maintenance treatment for a type of advanced ovarian cancer by the European Commission, following a panel’s consent in April. Lynparza, being jointly developed by AstraZeneca along with Merck & Co., can now be used in patients who are in response following chemotherapy for advanced BRCA-mutated ovarian cancer in Europe, AstraZeneca said. BRCA genes are responsible for producing proteins which repair damaged DNA, and if the genes are mutated, they can cause cancer growth. Lynparza belongs to a class of drugs known as PARP inhibitors which keep cancer cells damaged by chemotherapy from repairing themselves.

10) And Roche Holding AG’s (Basel CHE) push into personalized cancer medicines hit a milestone last week with Japanese approval of a new drug, Rozlytrek, that targets patients who must be identified via genetic profiling. Japan is the first country to give its blessing to Rozlytrek, also known as entrectinib, targeting people with NTRK fusion-positive solid tumors, across 10 different tumor types including breast, colorectal, neuroendocrine, lung and pancreatic cancers. This approach, where prospective patients must be identified via a biomarker test, is a departure from an era when doctors treated patients based on where the tumor occurred in the body.

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