The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Arzerra, a treatment for chronic lymphocytic leukemia, which is a cancer of the blood and bone marrow. The CHMP has recommended the drug for patients whose disease continues to progress despite receiving fludarabine and alemtuzumab, the current standard of care.

[ad]

Arzerra is also undergoing clinical trials for rheumatoid arthritis. It was also in testing for non-Hodgkin’s lymphoma, but produced underwhelming results for that indication. The treatment was approved by U.S. regulators just a few months ago. GSK licensed the drug, also known as ofatumumab or HuMax CD-20, in 2007 for $2.1 billion.

Source: FierceBiotech

Popularity: 2% [?]

The European Medicines Agency has recommended to the European Commission that an additional vaccine against influenza A(H1N1) (’swine flu’), Celvapan from Baxter, be granted a marketing authorisation. Adoption of an authorisation decision by the European Commission is expected shortly. This recommendation follows the authorisation of Focetria, from Novartis, and Pandemrix, from GlaxoSmithKline, by the European Commission on 29 September 2009.

[ad]

As for Focetria and Pandemrix, this recommendation will allow the manufacturer to replace the flu virus strain in the current ‘mock-up’ vaccine with the A(H1N1)v strain causing the current pandemic.

Celvapan is a non-adjuvanted vaccine. This means that it does not contain ‘adjuvants’ to enhance the immune response. The Committee for Medicinal Products for Human Use (CHMP) is currently recommending a two-dose vaccination schedule, at an interval of three weeks, for adults, including pregnant women, and for children from six months of age. Clinical trials in adults and in children are ongoing, and more results will become available from mid-October 2009 onwards.

Vaccination strategies are decided by the government in each European Union (EU) Member State, taking the information provided by the Agency for each pandemic vaccine into account.

As with all medicines, rare adverse reactions may only be detected once the vaccine is being used in large numbers of people. The Agency has requested that Baxter implement the same plans as for the other pandemic vaccines, to actively investigate and monitor the safety of Celvapan as soon as it is being used across the EU, so that action can be taken as early as possible if a safety issue emerges. As part of this, the manufacturer has committed to carry out post-authorisation safety studies in about 9,000 subjects.

[ad]

The Committee will continue to evaluate all information that becomes available, and make further recommendations if necessary, to ensure that the benefits of all pandemic vaccines outweigh their risks, taking into account the spread and severity of the pandemic.

Other applications for marketing authorisations for pandemic vaccines are still under review.

Source: PHARMANEWS.EU

Popularity: 3% [?]

Pivotal Registration Trial of OPAXIO Maintenance Therapy in First-Line Ovarian Cancer Reaches Enrollment Milestone of 600 patients, Cell Therapeutics and the Gynecologic Oncology Group Discuss Potential for Early Interim Analysis.

Cell Therapeutics, Inc. (“CTI”) (NASDAQ and MTA: CTIC) announced today that it will re-focus its resources on the approval of OPAXIO(TM) for its potential superiority indication in maintenance therapy for ovarian cancer. The Gynecologic Oncology Group (GOG) is conducting an ongoing phase III trial that evaluates the use of 12 months of OPAXIO therapy versus an untreated control arm. To date, 600 patients have been enrolled in this trial. CTI has discussed with the GOG, several strategies for conducting an interim analysis which could potentially result in an earlier registration. In addition, given the encouraging results of treatment of advanced esophageal cancer with OPAXIO to be reported at the upcoming International Society of Gastrointestinal Oncology Annual Meeting, CTI plans on meeting with the Food and Drug Administration (FDA) to discuss an additional registration study utilizing OPAXIO as a radiation sensitizer in the treatment of advanced esophageal cancer.

[ad]

CTI has notified the European Medicines Agency (EMEA) of its decision to withdraw its Marketing Authorization Application (MAA) for a non-inferiority indication in non-small cell lung cancer (NSCLC).

“Given that we have reached a milestone in the ovarian cancer trial enrollment coupled with the reservations the Committee for Medicinal Products for Human Use (CHMP) expressed about the control arm activity in the NSCL cancer study we believe it makes best sense for CTI to focus its efforts with OPAXIO on superiority applications like the first-line ovarian cancer trial as well as the exciting new potential application as a radiation sensitizer,” noted Craig W. Philips, President of CTI. “Both of these studies would be landmark trials and first in class for this novel bioengineered taxane. We look forward to continuing to work with the GOG and ultimately the FDA on a registration pathway for OPAXIO.”

“We believe focusing on ovarian maintenance, and radiosensitization, not only address areas of unmet medical need, but are in the best long term strategic interest of CTI. With the FDA review of the NDA for pixantrone in relapsed/refractory non-Hodgkin’s lymphoma well underway and the phase III Ovarian trial of OPAXIO progressing nicely we are pleased with the advancement and future potential of these novel treatments,” said James A. Bianco, M.D., CEO of CTI.

CTI has an existing license and co-development agreement with Novartis for OPAXIO(TM) (paclitaxel poliglumex, CT-2103), which also provides Novartis with an option to enter into an exclusive worldwide license to develop and commercialize pixantrone based upon agreed terms.

Source: PR Newswire

Popularity: 4% [?]

The European Medicines Agency announced that manufacturers have started submitting data on influenza A (H1N1) vaccines under an accelerated and rolling review process, with preliminary results from human trials expected beginning in September. The agency noted that the EU has already approved a total of four mock-up vaccines by GlaxoSmithKline, Novartis and Baxter based on earlier data generated with the H5N1 influenza virus.

[ad]

Monika Benstetter, a spokesperson for the EMEA, said the agency will be evaluating data as it becomes available, and “by the time an actual application is filed, it can be looked at in a very short time frame because basically we have already seen most of it.” With regard to the mock-up vaccines, the agency said the candidates have already been tested in more than 8000 people and that “experience with seasonal influenza vaccines indicate that insertion of a new strain in a vaccine, as will apply with the change from H5N1 to H1N1…should not substantially affect the safety or level of protection offered.”

The agency added that a number of other pandemic influenza vaccines are also currently under development, and preliminary data from GlaxoSmithKline and Sanofi Pasteur, the vaccines division of sanofi-aventis, are being assessed by the EMEA’s Committee for Medicinal Products for Human Use on a fast-track basis. However, Benstetter noted that these products will be produced “from scratch and that [will] take longer for the vaccines to become available” than those developed through the mock-up route.

Source: FirstWord

Popularity: 3% [?]

A European Medicines Agency committee did the unexpected late yesterday, recommending that the cancer drug Erbitux be rejected as a treatment for non-small-cell lung cancer.

That caught the investment community by surprise, according to DJ Newswires and Bloomberg. A Q&A about the refusal was posted on the European Union regulator’s Web site today.

[ad]

Shares of Merck KGaA, which markets Erbitux in Europe, were down over 14% in today’s trading in Frankfurt. Investors also weren’t pleased with second quarter earnings posted by the German company, which isn’t related to U.S.-based Merck. Bristol-Myers and Eli Lilly, which co-market Erbitux in the U.S., were relatively unaffected in early New York Stock Exchange Trading.

Merck thought the committee might impose some restrictions on the product’s use, as both the EU and U.S. regulators have required for Erbitux treatments in other patient populations.

“We never detected that a no-approval could be an option,” Elmar Schnee, chief of Merck’s drugs unit, said on a conference call with analysts. Merck will appeal the decision but expects a year’s delay in the drug launch even if Erbitux is approved for this use, notes DJ Newswires.

The committee felt that the benefits of Erbitux, when added to chemotherapy, were “modest in terms of survival times” and didn’t appear to slow down the cancer. And, side effects for patients could be severe, according to the document released today.

“The benefits of Erbitux in the treatment of non-small cell lung cancer did not outweigh its risks,” wrote the committee.

Source: The Wall Street Journal

Popularity: 3% [?]

Merck KGaA announced on Thursday that it filed cladribine with the European Medicines Agency for approval as a treatment for patients with relapsing-remitting multiple sclerosis. If approved, cladribine “could become the first orally administered disease-modifying therapy” for MS, the drugmaker said.

[ad]

The application is supported by findings from the CLARITY study, which demonstrated that short-course treatment with cladribine significantly reduced the rate of clinical relapses, disability progression and brain lesions in patients with relapsing-remitting MS. Detailed results from this trial were reported at the American Academy of Neurology annual conference in April.

Merck confirmed it is currently submitting new drug applications for cladribine in several other countries, including the US.

Source: FirstWord

Popularity: 4% [?]

The European Medicines Agency announced Thursday that it was recommending the gradual withdrawal of dextropropoxyphene-containing drugs after concluding that the risks associated with the products, which are used to treat acute and chronic pain, outweigh their benefits. The agency explained that “a significant number of deaths associated with overdose” were revealed during a safety and efficacy review of the medicines.

[ad]

According to the EMEA, the Committee for Medicinal Products for Human Use suggested the action “because no other adequate measures could be identified to minimise these risks sufficiently.” In addition, the regulator stated that based on available data, drugs containing dextropropoxyphene were not shown to be more effective than other pain treatments. The recommendation has been sent to the European Commission for the adoption of a legally binding decision.

Sanofi-aventis was reported to have said on Thursday that it would halt European sales of its products containing dextropropoxyphene. In the US, where the drug is known as propoxyphene, external advisers to the FDA recommended in January that products containing the ingredient be pulled from the market due to reports of fatal overdoses. A spokeswoman for the agency, Karen Riley, indicated that the FDA has not acted on the recommendations.

Source: FirstWord

Popularity: 2% [?]

AstraZeneca reported that the Netherlands Health Authority refused its application for Seroquel XR (quetiapine) in the treatment of recurrent depressive episodes in adults with major depressive disorder (MDD). The drugmaker, which said it referred the application to a committee of the European Medicines Agency for further assessment, also announced that the antipsychotic drug was approved in Canada this month for the treatment of MDD.

[ad]

Company spokesman Neil McCrae explained that the refusal in the Netherlands, which was acting as the reference member state for the mutual recognition process, was due to the regulator’s conclusion that there was a “negative benefit risk.” He explained that if the EMEA’s Committee for Medicinal Products for Human Use issues a positive opinion for Seroquel XR for the MDD indication, approval in the EU could be expected in the first quarter of 2010.

Source: FirstWord

Popularity: 4% [?]

OSI Pharmaceuticals on Thursday released results from a Phase III trial of Tarceva (erlotinib) in patients with advanced non-small-cell lung cancer, which showed positive results for the drug when used to treat the disease earlier than currently indicated. OSI noted that the study evaluated Tarceva as a single agent, first-line maintenance therapy for patients with advanced NSCLC who did not progress following first-line chemotherapy treatment.

[ad]

The SATURN trial enrolled 889 patients with advanced NSCLC who were treated with four cycles of standard first-line chemotherapy, followed by treatment with either Tarceva or placebo if their cancer did not progress. For the primary endpoint of progression-free survival in the overall population, data showed that patients who took Tarceva lived a median of 12.3 weeks without their disease worsening, compared with 11.1 weeks for those who received placebo. OSI also said the study met a second co-primary endpoint of PFS in patients with EGFR-positive tumours.

Regarding the result for Tarceva PFS in the overall population, OSI stated that the figures were not representative of patient benefit because of data distribution. CEO Colin Goddard remarked that the average benefit in patients who took Tarceva was 22 weeks, compared with 16 weeks for those who took placebo. The results were released ahead of a presentation of the data scheduled for later this month at ASCO.

Goddard estimated that use of Tarceva as maintenance therapy in NSCLC would add more than $500 million to the product’s annual US sales within one to three years of approval for this indication, which the company expects could be granted in 2010. Sales of Tarceva in the US, where it is co-marketed with Genentech, were $457 million in 2008. The drug has already been filed for expanded approval with the FDA, and with the European Medicines Agency by OSI’s international partner Roche.

Source: FirstWord

Popularity: 3% [?]

AstraZeneca announced Thursday that a committee of the European Medicines Agency recommended approval for Iressa (gefitinib) in adults with locally advanced or metastatic non-small-cell lung cancer (NSCLC) with activating mutations of EGFR-TK.

[ad]

The positive opinion stipulates, however, that the drugmaker must conduct a study to generate further data in a Caucasian population of patients with NSCLC. The drugmaker said it is in talks with the Committee for Medicinal Products for Human Use to finalise the design and endpoints of the trial.

Popularity: 3% [?]